The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Barrier Extra Protection Plus Face Mask.
Device ID | K920108 |
510k Number | K920108 |
Device Name: | BARRIER EXTRA PROTECTION PLUS FACE MASK |
Classification | Mask, Surgical |
Applicant | JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington, TX 76004 -3130 |
Contact | Wendt |
Correspondent | Wendt 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 | 1992-01-10 |
Decision Date | 1994-02-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07323190046058 | K920108 | 000 |
07333350550288 | K920108 | 000 |
07323190000586 | K920108 | 000 |
07323190000647 | K920108 | 000 |
07323190000913 | K920108 | 000 |
07323190001118 | K920108 | 000 |
07323190045181 | K920108 | 000 |
07323190045907 | K920108 | 000 |
07323190045938 | K920108 | 000 |
07323190045990 | K920108 | 000 |
07333350623876 | K920108 | 000 |