Lac-Mac Limited
LONDON Ontario, CA
LAC-MAC LIMITED appears in FDA device records in LONDON Ontario, CA. FDA records list 6 510(k) clearances between and , no 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 6 510(k) clearances for Lac-Mac Limited between 2003 and 2011. The busiest year on record is 2003, with 2. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 2 |
| 2004 | 1 |
| 2006 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102864 | 84E SERIES SINGLE PLY WRAPPER | FRG | Substantially Equivalent | |
| K092344 | LAC-MAC INNERBLOC LR SURGICAL GOWNS | FYA | Substantially Equivalent | |
| K061491 | LAC-MAC INNERBLOC O.R. GOWN | FYA | Substantially Equivalent | |
| K032631 | INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) | FYA | Substantially Equivalent | |
| K031362 | LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS | KKX | Substantially Equivalent | |
| K030536 | LAC-MAC LIMITED INNERBLOC O.R. GOWN | FYA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8022129 | 6499 | LAC-MAC LIMITED | 847 HIGHBURY AVE, LONDON Ontario N5Y 5B8 CA | 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