K162258 is an FDA 510(k) clearance for the Self Sealing Sterilization Pouches. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Tianchang Jiarui Packaging Material Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on April 28, 2017, 260 days after receiving the submission on August 11, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K162258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2016 |
| Decision Date | April 28, 2017 |
| Days to Decision | 260 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 |