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 |