Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K190797 |
Device Name |
Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) |
Applicant |
Reed Medical (Zhejiang) Co., Ltd. |
8th Floor, 10th Building, No. 988 of Xinxing Two Road |
EDZ of Pinghu |
Pinghu,
CN
314200
|
|
Applicant Contact |
Lu Zhong Zhong |
Correspondent |
Shanghai Qisheng Business Consulting Co., Ltd. |
Room 1301, Bld 46, Jing Gu Zhong Rd. No. 58, Min Hang |
District, Shanghai, CN |
Shanghai,
CN
200240
|
|
Correspondent Contact |
Daniel Qiu |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 03/28/2019 |
Decision Date | 11/18/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|