The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Barrier Laser Plus Face Mask.
| Device ID | K934194 |
| 510k Number | K934194 |
| Device Name: | BARRIER LASER PLUS FACE MASK |
| Classification | Mask, Surgical |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington, TX 76004 -3130 |
| Contact | Darrell Thompson |
| Correspondent | Darrell Thompson JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington, TX 76004 -3130 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-26 |
| Decision Date | 1994-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07323190000760 | K934194 | 000 |
| 07323190000524 | K934194 | 000 |