K951590 is an FDA 510(k) clearance for the ASSURE, SELF-SEALING STERILIZATION POUCH. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Sultan Chemists, Inc. (Englewood, US). The FDA issued a Cleared decision on May 17, 1995, 41 days after receiving the submission on April 6, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K951590 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1995 |
| Decision Date | May 17, 1995 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| 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 |