The following data is part of a premarket notification filed by Tianchang Jiarui Packaging Material Co., Ltd. with the FDA for Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted.
| Device ID | K181957 |
| 510k Number | K181957 |
| Device Name: | Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted |
| Classification | Wrap, Sterilization |
| Applicant | Tianchang Jiarui Packaging Material Co., Ltd. Yeshan Industria Zone Tianchang, CN 239300 |
| Contact | Zhang Ruiqing |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-23 |
| Decision Date | 2019-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D930321160120 | K181957 | 000 |
| D930321160110 | K181957 | 000 |
| D930321160100 | K181957 | 000 |
| D930321160090 | K181957 | 000 |
| D930321160080 | K181957 | 000 |
| D930321160070 | K181957 | 000 |