The following data is part of a premarket notification filed by Lorrex Health Products with the FDA for Lorex Tracheostomy Gauze Sponges - Sterile 1's And 2's.
| Device ID | K941955 |
| 510k Number | K941955 |
| Device Name: | LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S |
| Classification | Gauze/sponge, Internal |
| Applicant | LORREX HEALTH PRODUCTS 301 PENHORN AVE. Secaucus, NJ 07094 |
| Contact | Eric Morales |
| Correspondent | Eric Morales LORREX HEALTH PRODUCTS 301 PENHORN AVE. Secaucus, NJ 07094 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-22 |
| Decision Date | 1994-05-12 |