The following data is part of a premarket notification filed by Weihai Xingtai Packaging Products Co.,ltd. with the FDA for Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch.
| Device ID | K193561 |
| 510k Number | K193561 |
| Device Name: | Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch |
| Classification | Wrap, Sterilization |
| Applicant | Weihai Xingtai Packaging Products Co.,Ltd. Sunjiatan Industrial Zone, Yangting Town, Huancui Area Weihai, CN 264200 |
| Contact | Miao Qifen |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-23 |
| Decision Date | 2020-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009046481 | K193561 | 000 |
| 00860009046474 | K193561 | 000 |
| 00860009046467 | K193561 | 000 |
| 00840169153793 | K193561 | 000 |