The following data is part of a premarket notification filed by E.w.a., Ltd. with the FDA for Usp Type Vii Gauze Sponges.
| Device ID | K923378 |
| 510k Number | K923378 |
| Device Name: | USP TYPE VII GAUZE SPONGES |
| Classification | Gauze / Sponge,nonresorbable For External Use |
| Applicant | E.W.A., LTD. 164 FLINT ROCK DR. Lakewood, NJ 08701 |
| Contact | Wells, Jr. |
| Correspondent | Wells, Jr. E.W.A., LTD. 164 FLINT ROCK DR. Lakewood, NJ 08701 |
| Product Code | NAB |
| CFR Regulation Number | 878.4014 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-09 |
| Decision Date | 1992-10-06 |