The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Anogo Disposable Shoe Cover.
| Device ID | K812105 |
| 510k Number | K812105 |
| Device Name: | ANOGO DISPOSABLE SHOE COVER |
| Classification | Shoe And Shoe Cover, Conductive |
| Applicant | ANAGO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BWP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-24 |
| Decision Date | 1981-09-11 |