The following data is part of a premarket notification filed by American Medical Manufacturer, Inc. with the FDA for Sponge Counter.
| Device ID | K926225 |
| 510k Number | K926225 |
| Device Name: | SPONGE COUNTER |
| Classification | Operating Room Accessories Table Tray |
| Applicant | AMERICAN MEDICAL MANUFACTURER, INC. 21026 OSBORNE ST. Canoga Park, CA 91304 |
| Contact | Mike Hoftman |
| Correspondent | Mike Hoftman AMERICAN MEDICAL MANUFACTURER, INC. 21026 OSBORNE ST. Canoga Park, CA 91304 |
| Product Code | FWZ |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-10 |
| Decision Date | 1993-03-05 |