K021992 is an FDA 510(k) clearance for the DHS DISPOSABLE HOOD SYSTEM. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 14, 2003, 210 days after receiving the submission on June 18, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K021992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2002 |
| Decision Date | January 14, 2003 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |