The following data is part of a premarket notification filed by Selomas, Inc. with the FDA for Gauze Sponges Usp Type Vii.
| Device ID | K861215 |
| 510k Number | K861215 |
| Device Name: | GAUZE SPONGES USP TYPE VII |
| Classification | Gauze/sponge, Internal |
| Applicant | SELOMAS, INC. SETON CENTER 950 FORGE AVE. Norristown, PA 19403 |
| Contact | Kenneth E Cleaver |
| Correspondent | Kenneth E Cleaver SELOMAS, INC. SETON CENTER 950 FORGE AVE. Norristown, PA 19403 |
| 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 | 1986-03-31 |
| Decision Date | 1986-04-17 |