The following data is part of a premarket notification filed by Johnson & Johnson Medical, Div. Of Ethicon, Inc. with the FDA for Barrier Surgical Gowns.
Device ID | K990395 |
510k Number | K990395 |
Device Name: | BARRIER SURGICAL GOWNS |
Classification | Gown, Surgical |
Applicant | JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. 2500 EAST ARBROOK BLVD. Arlington, TX 76014 -3631 |
Contact | Jane Ann Martin |
Correspondent | Jane Ann Martin JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. 2500 EAST ARBROOK BLVD. Arlington, TX 76014 -3631 |
Product Code | FYA |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-09 |
Decision Date | 1999-04-13 |
Summary: | summary |