K941466 is an FDA 510(k) clearance for the SURGICAL INSTRUMENTS KIT. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Clinical Resources, Inc. (Elgin, US). The FDA issued a Cleared decision on April 22, 1994, 25 days after receiving the submission on March 28, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K941466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | March 28, 1994 |
| Decision Date | April 22, 1994 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |