The following data is part of a premarket notification filed by Zhejiang Chuangxiang Medical Technology Co., Ltd. with the FDA for Rotatable Snares, Non-rotatable Snares.
Device ID | K172758 |
510k Number | K172758 |
Device Name: | Rotatable Snares, Non-Rotatable Snares |
Classification | Snare, Flexible |
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 | FDI |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-13 |
Decision Date | 2018-03-07 |
Summary: | summary |