The following data is part of a premarket notification filed by Zhejiang Chuangxiang Medical Technology Co., Ltd. with the FDA for Single Use Grasping Forceps.
Device ID | K191900 |
510k Number | K191900 |
Device Name: | Single Use Grasping Forceps |
Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
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 | OCZ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-07-16 |
Decision Date | 2020-03-27 |