The following data is part of a premarket notification filed by Bfd, Inc. with the FDA for Combo-shield.
| Device ID | K882027 |
| 510k Number | K882027 |
| Device Name: | COMBO-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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817583020543 | K882027 | 000 |
| 20817583020530 | K882027 | 000 |
| 20817583020516 | K882027 | 000 |
| 20817583020509 | K882027 | 000 |