The following data is part of a premarket notification filed by Emerald Medical, Inc. with the FDA for Emerald Sterile Gauze Sponge.
| Device ID | K961581 |
| 510k Number | K961581 |
| Device Name: | EMERALD STERILE GAUZE SPONGE |
| Classification | Gauze/sponge, Internal |
| Applicant | EMERALD MEDICAL, INC. 7-11 FACTORY LANE, SUITE 1 Middlesex, NJ 08846 |
| Contact | Patrick Mc Crann |
| Correspondent | Patrick Mc Crann EMERALD MEDICAL, INC. 7-11 FACTORY LANE, SUITE 1 Middlesex, NJ 08846 |
| 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 | 1996-04-24 |
| Decision Date | 1996-05-28 |