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 |