The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Guardall Shield.
Device ID | K915415 |
510k Number | K915415 |
Device Name: | GUARDALL SHIELD |
Classification | Accessory, Surgical Apparel |
Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Contact | Jill Albritton |
Correspondent | Jill Albritton ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Product Code | LYU |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-29 |
Decision Date | 1992-10-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GUARDALL SHIELD 73721261 1510028 Live/Registered |
ANAGO, INC. 1988-04-08 |