The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Anago Fem-cool/fem-cool Petite.
| Device ID | K926137 |
| 510k Number | K926137 |
| Device Name: | ANAGO FEM-COOL/FEM-COOL PETITE |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
| Contact | Jill D Albritton |
| Correspondent | Jill D Albritton ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-07 |
| Decision Date | 1993-05-26 |