The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Barrier Fabric 450 Surgical Gown.
| Device ID | K934608 |
| 510k Number | K934608 |
| Device Name: | BARRIER FABRIC 450 SURGICAL GOWN |
| Classification | Gown, Surgical |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington, TX 76004 -3130 |
| Contact | Linda G Hill |
| Correspondent | Linda G Hill JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington, TX 76004 -3130 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-27 |
| Decision Date | 1994-04-11 |