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 | K910557 |
510k Number | K910557 |
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 | T. M Wendt |
Correspondent | T. M 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 | 1991-02-08 |
Decision Date | 1991-04-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07323190043279 | K910557 | 000 |