K111810 is an FDA 510(k) clearance for the AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS. This device is classified as a Sterilizer, Chemical (Class II - Special Controls, product code MLR).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on September 2, 2011, 67 days after receiving the submission on June 27, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K111810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2011 |
| Decision Date | September 02, 2011 |
| Days to Decision | 67 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MLR — Sterilizer, Chemical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |