The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Guardall Shield.
Device ID | K875008 |
510k Number | K875008 |
Device Name: | GUARDALL SHIELD |
Classification | Mask, Surgical |
Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Contact | Gary W Pedersen |
Correspondent | Gary W Pedersen ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-04 |
Decision Date | 1988-03-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GUARDALL SHIELD 73721261 1510028 Live/Registered |
ANAGO, INC. 1988-04-08 |