The following data is part of a premarket notification filed by Lorrex Health Products with the FDA for Round Stick Sponges, Flat Stick Sponges.
| Device ID | K945553 |
| 510k Number | K945553 |
| Device Name: | ROUND STICK SPONGES, FLAT STICK SPONGES |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | LORREX HEALTH PRODUCTS 301 PENHORN AVE. Secaucus, NJ 07094 |
| Contact | David M Pieratos |
| Correspondent | David M Pieratos LORREX HEALTH PRODUCTS 301 PENHORN AVE. Secaucus, NJ 07094 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-10 |
| Decision Date | 1994-12-28 |