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 |
07333350620141 | K934194 | 000 |
07333350794071 | K934194 | 000 |