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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 K162778
Device Name Portable Slit Lamp Microscope
Applicant
Suzhou Kangjie Medical, Inc.
# 129, Weixin Rd., Weiting Town
Suzhou,  CN 215000
Applicant Contact Hong Zhu
Correspondent
Di WU Regulatory
3440 Indian Queen Ln., Rear
Philadelphia,  PA  19129
Correspondent Contact Di Wu
Regulation Number886.1850
Classification Product Code
HJO  
Date Received09/30/2016
Decision Date 07/21/2017
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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