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 |