K220564 is an FDA 510(k) clearance for the 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on May 23, 2022, 84 days after receiving the submission on February 28, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K220564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2022 |
| Decision Date | May 23, 2022 |
| Days to Decision | 84 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 |