K071087 is an FDA 510(k) clearance for the VIS-U-ALL II HEAT-SEAL POUCH AND TUBING. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on October 16, 2007, 182 days after receiving the submission on April 17, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K071087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2007 |
| Decision Date | October 16, 2007 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |