The following data is part of a premarket notification filed by American Healthcare Corp. with the FDA for Gauze Sponges, Internal And External.
| Device ID | K905136 |
| 510k Number | K905136 |
| Device Name: | GAUZE SPONGES, INTERNAL AND EXTERNAL |
| Classification | Gauze/sponge, Internal |
| Applicant | AMERICAN HEALTHCARE CORP. 30 CRAIG ST. BRANTFORD, ONTARIO N3T 5M9 Canada, CA |
| Contact | Carol Mason |
| Correspondent | Carol Mason AMERICAN HEALTHCARE CORP. 30 CRAIG ST. BRANTFORD, ONTARIO N3T 5M9 Canada, CA |
| 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 | 1990-11-15 |
| Decision Date | 1991-03-06 |