The following data is part of a premarket notification filed by Vitalcare Group, Inc. with the FDA for Gauze, Sponges, Cat # 11-003.
| Device ID | K983016 |
| 510k Number | K983016 |
| Device Name: | GAUZE, SPONGES, CAT # 11-003 |
| Classification | Gauze/sponge, Internal |
| Applicant | VITALCARE GROUP, INC. 15800 N.W. 13TH AVE. Miami, FL 33169 |
| Contact | Ginger Talley |
| Correspondent | Ginger Talley VITALCARE GROUP, INC. 15800 N.W. 13TH AVE. Miami, FL 33169 |
| 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 | 1998-08-28 |
| Decision Date | 1999-02-12 |