The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Anago Disp., All Purpose Patient Rest..
| Device ID | K800197 |
| 510k Number | K800197 |
| Device Name: | ANAGO DISP., ALL PURPOSE PATIENT REST. |
| Classification | Bandage, Elastic |
| Applicant | ANAGO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FQM |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-30 |
| Decision Date | 1980-02-26 |