The following data is part of a premarket notification filed by Tianchang Jiarui Packaging Material Co., Ltd. with the FDA for Self Sealing Sterilization Pouches.
| Device ID | K162258 |
| 510k Number | K162258 |
| Device Name: | Self Sealing Sterilization Pouches |
| Classification | Wrap, Sterilization |
| Applicant | Tianchang Jiarui Packaging Material Co., Ltd. Yeshan Industria Zone Tianchang, CN 239300 |
| Contact | Zhang Ruiqing |
| Correspondent | Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No. 25 BanBiDian Rd., TongZhou District Beijing, CN 101121 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-11 |
| Decision Date | 2017-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00723896026342 | K162258 | 000 |
| 20665973027191 | K162258 | 000 |
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