K111519 is an FDA 510(k) clearance for the STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on October 3, 2012, 489 days after receiving the submission on June 2, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K111519 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2011 |
| Decision Date | October 03, 2012 |
| Days to Decision | 489 days |
| Submission Type | Traditional |
| 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 |