K070765 is an FDA 510(k) clearance for the VIS-U-ALL II SELF SEAL POUCH. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on October 12, 2007, 206 days after receiving the submission on March 20, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K070765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2007 |
| Decision Date | October 12, 2007 |
| Days to Decision | 206 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 |