The following data is part of a premarket notification filed by Zhejiang Chuangxiang Medical Technology Co., Ltd. with the FDA for Disposable Valve Sets.
| Device ID | K192258 |
| 510k Number | K192258 |
| Device Name: | Disposable Valve Sets |
| Classification | Endoscope Channel Accessory |
| Applicant | Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road Hanzhou, CN 311100 |
| Contact | Lucius Long |
| Correspondent | Lucius Long Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road Hanzhou, CN 311100 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-20 |
| Decision Date | 2019-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16970401815095 | K192258 | 000 |
| 16970401818867 | K192258 | 000 |