The following data is part of a premarket notification filed by Medical Action Industries, Inc. with the FDA for Gauze Sponge.
| Device ID | K884826 |
| 510k Number | K884826 |
| Device Name: | GAUZE SPONGE |
| Classification | Gauze/sponge, Internal |
| Applicant | MEDICAL ACTION INDUSTRIES, INC. 1934 NEW HWY. Farmingdale, NY 11735 |
| Contact | John Giagu |
| Correspondent | John Giagu MEDICAL ACTION INDUSTRIES, INC. 1934 NEW HWY. Farmingdale, NY 11735 |
| 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 | 1988-11-18 |
| Decision Date | 1988-12-22 |