K070895 is an FDA 510(k) clearance for the VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on September 5, 2007, 159 days after receiving the submission on March 30, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K070895 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2007 |
| Decision Date | September 05, 2007 |
| Days to Decision | 159 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JOJ — Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |