The following data is part of a premarket notification filed by American Convertors Div., American Pharmaseal with the FDA for Shield Perfect Fit; Dura-fit, Dispos..
| Device ID | K800528 |
| 510k Number | K800528 |
| Device Name: | SHIELD PERFECT FIT; DURA-FIT, DISPOS. |
| Classification | Cover, Shoe, Operating-room |
| Applicant | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FXP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-07 |
| Decision Date | 1980-04-16 |