The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Disposable Surgery Caps & Hoods.
| Device ID | K810199 |
| 510k Number | K810199 |
| Device Name: | DISPOSABLE SURGERY CAPS & HOODS |
| Classification | Cap, Surgical |
| Applicant | ANAGO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FYF |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-23 |
| Decision Date | 1981-02-13 |