K182184 is an FDA 510(k) clearance for the Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted). This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Mdk (Shanghai) Medical Packing Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 10, 2019, 423 days after receiving the submission on August 13, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K182184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2018 |
| Decision Date | October 10, 2019 |
| Days to Decision | 423 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 |