The following data is part of a premarket notification filed by American Convertors Div., American Pharmaseal with the FDA for Tomac Sterile Disp. Lap Sponge.
| Device ID | K812554 |
| 510k Number | K812554 |
| Device Name: | TOMAC STERILE DISP. LAP SPONGE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-08 |
| Decision Date | 1981-09-24 |