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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K153545
Device Name Portable Slit Lamp
Applicant
Shanghai Bolan Optical-Electric Co., Ltd.
#29, Jiuyuan Rd., Qingpu Industrial Park, Shanghai ,
Shanghai,  CN 201700
Applicant Contact Johnny Hu
Correspondent
Shanghai Bolan Optical-Electric Co., Ltd.
#29, Jiuyuan Rd., Qingpu Industrial Park, Shanghai ,
Shanghai,  CN 201700
Correspondent Contact Johnny Hu
Regulation Number886.1850
Classification Product Code
HJO  
Date Received12/11/2015
Decision Date 06/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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