The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Receiving Blanket.
Device ID | K904274 |
510k Number | K904274 |
Device Name: | RECEIVING BLANKET |
Classification | Bedding, Disposable, Medical |
Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Contact | Ann Faulkner |
Correspondent | Ann Faulkner ANAGO, INC. 7524 MOSIER VIEW CT. 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 | 1990-09-18 |
Decision Date | 1990-10-26 |