The following data is part of a premarket notification filed by Lorrex Health Products with the FDA for Lorrex Cover Sponges Sterile2's And Non-sterile.
Device ID | K942070 |
510k Number | K942070 |
Device Name: | LORREX COVER SPONGES STERILE2'S AND NON-STERILE |
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 | 1994-04-29 |
Decision Date | 1994-05-19 |