Contamac Ltd.
ESSEX UK Essex, GB
CONTAMAC LTD. appears in FDA device records in ESSEX UK Essex, GB. FDA records list 18 510(k) clearances between and , 3 PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Contamac Ltd. between 2002 and 2022. The busiest year on record is 2003, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 3 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | HQD | Substantially Equivalent | |
| K182304 | Hyper GP (tisilfocon A) Daily Wear Contact Lens | HQD | Substantially Equivalent | |
| K181566 | Nutrifill | MRC | Substantially Equivalent | |
| K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens | HQD | Substantially Equivalent | |
| K171575 | ENFLU 18 (enflufocon A) Daily Wear Contact Lens | HQD | Substantially Equivalent | |
| K171077 | HEXA100 (hexafocon A) Daily Wear Contact Lenses | HQD | Substantially Equivalent | |
| K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | HQD | Substantially Equivalent | |
| K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | MUW | Substantially Equivalent | |
| K150590 | CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear, | LPL | Substantially Equivalent | |
| K081178 | OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES | HQD | Substantially Equivalent | |
| K070628 | OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. | HQD | Substantially Equivalent | |
| K062548 | MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES | HQD | Substantially Equivalent | |
| K033594 | OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES | HQD | Substantially Equivalent | |
| K023989 | CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | LPL | Substantially Equivalent | |
| K023987 | CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | LPL | Substantially Equivalent | |
| K024045 | CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | LPL | Substantially Equivalent | |
| K023349 | CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | LPL | Substantially Equivalent | |
| K021977 | HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR | HQD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3001190611 | 3001190611 | CONTAMAC LTD. | CARLTON HOUSE, ESSEX UK CB11 3AU GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain