The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Provision Surgical Helmet System.
| Device ID | K972832 |
| 510k Number | K972832 |
| Device Name: | PROVISION SURGICAL HELMET SYSTEM |
| Classification | Gown, Surgical |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Cherlly K Hastings |
| Correspondent | Cherlly K Hastings DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-30 |
| Decision Date | 1997-10-21 |
| Summary: | summary |