K933729 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 June 21, 1994, 323 days after receiving the submission on August 2, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K933729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1993 |
| Decision Date | June 21, 1994 |
| Days to Decision | 323 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |