510(k) K172151
- Device
- Hysteroscopy System
- Applicant
- Chongquin Jinshan Science & Technology (Group) Co., Ltd.
- 510(k) number
- K172151
- Product code
- HGH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-09
- Date received
- 2017-07-17
- Regulation
- 884.5070
- Classification name
- Cannula, Suction, Uterine
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Qing Xu
- Address
- Yubei District #18 Ningshang Ave. Jinshan International Industrial City Chongqing CN 400000 400000
FDA Registration Numbers#
- 1450908
- 8044099
- 3011219572
- 3008007615
- 3014615028
Source Documents#
Other 510(k) Records For Product Code HGH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161106 | PANPAC DISPOSABLE VACUUM CURETTES | Panpac Medical Corporation | 2017-01-13 |
| K140213 | DISPOSABLE ENDOSCOPIC CANNULA | Dongguan Microview Medical Technology Co., Ltd. | 2015-03-25 |
| K093508 | RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) | Womancare Global | 2010-03-04 |
| K935820 | KOLSTER METHODS | Kolster Methods | 1994-07-19 |
| K840285 | NON STRESS TEST MONITOR 507 | Imex Medical Systems, Inc. | 1984-05-09 |
Legacy Summary#
summary
FDA Review#
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