K191741 is an FDA 510(k) clearance for the Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Intertape Polymer, Inc. (Sarasota, US). The FDA issued a Cleared decision on August 2, 2019, 32 days after receiving the submission on July 1, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K191741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2019 |
| Decision Date | August 02, 2019 |
| Days to Decision | 32 days |
| Submission Type | Special |
| 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 |