K183356 is an FDA 510(k) clearance for the Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Weihai Xingtai Packaging Products Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on August 19, 2019, 258 days after receiving the submission on December 4, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K183356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2018 |
| Decision Date | August 19, 2019 |
| Days to Decision | 258 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 |