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 |
|---|---|---|
| 10840326419448 | K162258 | 000 |
| 00615375011812 | K162258 | 000 |
| 00615375011782 | K162258 | 000 |
| 10843717103445 | K162258 | 000 |
| 10843717103452 | K162258 | 000 |
| 10843717103469 | K162258 | 000 |
| 10843717103476 | K162258 | 000 |
| 10843717103483 | K162258 | 000 |
| 10843717103490 | K162258 | 000 |
| D806MBFC1 | K162258 | 000 |
| 00665973027173 | K162258 | 000 |
| 20665973027207 | K162258 | 000 |
| 20665973027191 | K162258 | 000 |
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| 20665973027146 | K162258 | 000 |
| 20665973027153 | K162258 | 000 |
| 20665973027160 | K162258 | 000 |
| 20665973027177 | K162258 | 000 |
| 20665973027184 | K162258 | 000 |
| D806STP32121 | K162258 | 000 |
| D806STP75131 | K162258 | 000 |
| D806STP10151 | K162258 | 000 |
| D806STP2251 | K162258 | 000 |
| D806STP291 | K162258 | 000 |
| D806STP35101 | K162258 | 000 |
| D806STP35101001 | K162258 | 000 |
| D806STP35651 | K162258 | 000 |
| D806STP52111 | K162258 | 000 |
| D806STP52751 | K162258 | 000 |
| D806STP75131001 | K162258 | 000 |
| 10615375010331 | K162258 | 000 |
| 10615375010324 | K162258 | 000 |
| 10615375010317 | K162258 | 000 |
| 10615375010225 | K162258 | 000 |
| 10615375010232 | K162258 | 000 |
| 10615375010249 | K162258 | 000 |
| 10615375010256 | K162258 | 000 |
| 10615375010263 | K162258 | 000 |
| 10615375010270 | K162258 | 000 |
| 10615375010287 | K162258 | 000 |
| 10615375010294 | K162258 | 000 |
| 10615375010300 | K162258 | 000 |
| D806STP27101 | K162258 | 000 |