The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Disposable Beard Cover.
Device ID | K904276 |
510k Number | K904276 |
Device Name: | DISPOSABLE BEARD COVER |
Classification | Hood, Surgical |
Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Contact | Ann Faulker |
Correspondent | Ann Faulker ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Product Code | FXY |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-19 |
Decision Date | 1990-11-21 |