The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Disposable Patient Blanket.
| Device ID | K843038 |
| 510k Number | K843038 |
| Device Name: | DISPOSABLE PATIENT BLANKET |
| Classification | Bedding, Disposable, Medical |
| Applicant | ANAGO, INC. 7337 DOGWOOD PARK Fort Worth , TX 76118 - |
| Contact | Sandy Keller |
| Correspondent | Sandy Keller ANAGO, INC. 7337 DOGWOOD PARK Fort Worth , TX 76118 - |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-02 |
| Decision Date | 1984-10-24 |