The following data is part of a premarket notification filed by E.w.a., Ltd. with the FDA for Gauze Sponge (e.w.a. Ltd./various).
| Device ID | K943339 |
| 510k Number | K943339 |
| Device Name: | GAUZE SPONGE (E.W.A. LTD./VARIOUS) |
| Classification | Gauze/sponge, Internal |
| Applicant | E.W.A., LTD. 35 BEAVERSON BLVD. BLDG. 8C Brick, NJ 08723 |
| Contact | Frank Wells |
| Correspondent | Frank Wells E.W.A., LTD. 35 BEAVERSON BLVD. BLDG. 8C Brick, NJ 08723 |
| 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 | 1994-07-12 |
| Decision Date | 1994-08-23 |