K112087 is an FDA 510(k) clearance for the TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on October 15, 2012, 452 days after receiving the submission on July 21, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K112087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2011 |
| Decision Date | October 15, 2012 |
| Days to Decision | 452 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 |