K091627 is an FDA 510(k) clearance for the SMITH & NEPHEW INSTRUMENT TRAYS. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on July 2, 2009, 29 days after receiving the submission on June 3, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K091627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2009 |
| Decision Date | July 02, 2009 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |