The following data is part of a premarket notification filed by Bfd, Inc. with the FDA for Add-a-shield.
Device ID | K882026 |
510k Number | K882026 |
Device Name: | ADD-A-SHIELD |
Classification | Mask, Surgical |
Applicant | BFD, INC. P.O. DRAWER 909 Gardendale, AL 35071 |
Contact | Patrick Russell |
Correspondent | Patrick Russell BFD, INC. P.O. DRAWER 909 Gardendale, AL 35071 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-13 |
Decision Date | 1988-06-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ADD-A-SHIELD 86799390 4992360 Live/Registered |
Healthier Environments, Inc. 2015-10-26 |