K961791 is an FDA 510(k) clearance for the DEPUY DISPOSABLE FILTER/HOOD. This device is classified as a Accessory, Surgical Apparel (Class I - General Controls, product code LYU).
Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 9, 1996, 92 days after receiving the submission on May 9, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K961791 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1996 |
| Decision Date | August 09, 1996 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LYU — Accessory, Surgical Apparel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4040 |