The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Sterile View Barrier Hood/gown With Hytrel.
| Device ID | K961239 |
| 510k Number | K961239 |
| Device Name: | DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL |
| Classification | Gown, Surgical |
| Applicant | DEPUY, INC. 2747 ARMSTRONG LN. Dayton, OH 45414 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings DEPUY, INC. 2747 ARMSTRONG LN. Dayton, OH 45414 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-01 |
| Decision Date | 1996-09-17 |
| Summary: | summary |