The following data is part of a premarket notification filed by A Plus International, Inc with the FDA for Bouffant Cap.
| Device ID | K882283 |
| 510k Number | K882283 |
| Device Name: | BOUFFANT CAP |
| Classification | Cap, Surgical |
| Applicant | A PLUS INTERNATIONAL, INC 275 S. 3RD AVE. #2 La Puente, CA 91746 |
| Contact | David Lee |
| Correspondent | David Lee A PLUS INTERNATIONAL, INC 275 S. 3RD AVE. #2 La Puente, CA 91746 |
| Product Code | FYF |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-31 |
| Decision Date | 1988-06-23 |