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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Bldg., # 988 Of Xinxing Two Rd.
Edz Of Pinghu
Pinghu,  CN 314200
Applicant Contact Lu Zhong Zhong
Correspondent
Shanghai Qisheng Business Consulting Co., Ltd.
Rm. 1301, Bld 46, Jing Gu Zhong Rd. # 58, Min Hang
District, Shanghai, Cn
Shanghai,  CN 200240
Correspondent Contact Daniel Qiu
Regulation Number884.1690
Classification Product Code
HIH  
Date Received03/28/2019
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
Predetermined Change
Control Plan Authorized		 No
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