The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Dhs Disposable Hood System.
| Device ID | K021992 |
| 510k Number | K021992 |
| Device Name: | DHS DISPOSABLE HOOD SYSTEM |
| Classification | Gown, Surgical |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Kacy Arnold |
| Correspondent | Kacy Arnold BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-18 |
| Decision Date | 2003-01-14 |
| Summary: | summary |