Mac Lee Medical Products
Mchenry, IL, US
Mac Lee Medical Products appears in FDA device records in Mchenry, IL. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Mac Lee Medical Products between 1979 and 1988. The busiest year on record is 1986, with 7. The most recent is 1988, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1983 | 1 |
| 1984 | 2 |
| 1986 | 7 |
| 1987 | 2 |
| 1988 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K872953 | DISPOSABLE I.V. ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K872006 | DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF | FGD | Substantially Equivalent | |
| K870995 | SCALP VEIN SET | FPA | Substantially Equivalent | |
| K864781 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC | FMF | Substantially Equivalent | |
| K864779 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC | FMF | Substantially Equivalent | |
| K864778 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC | FMF | Substantially Equivalent | |
| K864777 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC | FMF | Substantially Equivalent | |
| K864783 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC | FMF | Substantially Equivalent | |
| K864782 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC | FMF | Substantially Equivalent | |
| K864780 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC | FMF | Substantially Equivalent | |
| K841710 | MAC LEE VAGINAL IRRIGATOR | HED | Substantially Equivalent | |
| K841711 | MAC LEE SITZ BATH | KTC | Substantially Equivalent | |
| K830192 | MAC LEE UI URINE COLLECTION BAG | KNX | Substantially Equivalent | |
| K791863 | MAC LEE ENEMAD | FCE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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