The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Sterile View Disp. Hood/gown Uv, Barrier Hood, Uv.
| Device ID | K901536 |
| 510k Number | K901536 |
| Device Name: | STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV |
| Classification | Gown, Surgical |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Melinda A Wright |
| Correspondent | Melinda A Wright DEPUY, INC. P.O. BOX 988 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 | 1990-04-02 |
| Decision Date | 1990-11-29 |