The following data is part of a premarket notification filed by Bfd, Inc. with the FDA for Medical Eye Disposable Shield.
| Device ID | K875302 |
| 510k Number | K875302 |
| Device Name: | MEDICAL EYE DISPOSABLE SHIELD |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| 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 | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-29 |
| Decision Date | 1988-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817583023319 | K875302 | 000 |
| 20817583023289 | K875302 | 000 |
| 20817583023272 | K875302 | 000 |
| 20817583023265 | K875302 | 000 |
| 20817583023258 | K875302 | 000 |
| 20817583023241 | K875302 | 000 |
| 20817583023296 | K875302 | 000 |
| 20817583023302 | K875302 | 000 |