The following data is part of a premarket notification filed by A Plus International, Inc with the FDA for Gauze And Lap Sponges -sterile & Non-sterile.
| Device ID | K881395 |
| 510k Number | K881395 |
| Device Name: | GAUZE AND LAP SPONGES -STERILE & NON-STERILE |
| Classification | Gauze/sponge, Internal |
| Applicant | A PLUS INTERNATIONAL, INC 275 S. 3RD AVE. #2 La Puente, CA 91746 |
| Contact | David S Lee |
| Correspondent | David S Lee A PLUS INTERNATIONAL, INC 275 S. 3RD AVE. #2 La Puente, CA 91746 |
| 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 | 1988-04-04 |
| Decision Date | 1988-04-28 |