The following data is part of a premarket notification filed by American Convertors Div., American Pharmaseal with the FDA for Contura Dispos. Surg. Face Mask.
| Device ID | K813078 |
| 510k Number | K813078 |
| Device Name: | CONTURA DISPOS. SURG. FACE MASK |
| Classification | Mask, Surgical |
| Applicant | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-02 |
| Decision Date | 1981-12-18 |