K172207 is an FDA 510(k) clearance for the Standard Supreme Sterilization Wrapper. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on August 25, 2017, 35 days after receiving the submission on July 21, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K172207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2017 |
| Decision Date | August 25, 2017 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |