K152564 is an FDA 510(k) clearance for the Gemini Sterilization Wrap. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on July 7, 2016, 302 days after receiving the submission on September 9, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K152564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2015 |
| Decision Date | July 07, 2016 |
| Days to Decision | 302 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 |