K181957 is an FDA 510(k) clearance for the Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted. 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 July 9, 2019, 351 days after receiving the submission on July 23, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K181957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2018 |
| Decision Date | July 09, 2019 |
| Days to Decision | 351 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 |