The following data is part of a premarket notification filed by Chongquin Jinshan Science & Technology (group) Co., Ltd. with the FDA for Hysteroscopy System.
Device ID | K172151 |
510k Number | K172151 |
Device Name: | Hysteroscopy System |
Classification | Cannula, Suction, Uterine |
Applicant | Chongquin Jinshan Science & Technology (Group) Co., Ltd. Yubei District No. 18 Ningshang Avenue Jinshan International Industrial City Chongqing, CN 400000 |
Contact | Qing Xu |
Correspondent | Qing Xu Chongquin Jinshan Science & Technology (Group) Co., Ltd. Yubei District No. 18 Ningshang Avenue Jinshan International Industrial City Chongqing, CN 400000 |
Product Code | HGH |
CFR Regulation Number | 884.5070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-17 |
Decision Date | 2018-04-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06946332802261 | K172151 | 000 |
06946332802209 | K172151 | 000 |
06946332802148 | K172151 | 000 |
06946332802117 | K172151 | 000 |