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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Manual
510(k) Number K142263
Device Name Applanation Tonometer
Applicant
Shanghai Mediworks Precision Instruments Co. , Ltd.
Zone A, 2nd Floor, # 69, Lane
1985, Chunshen Rd. Minhang District,
Shanghai,  CN 200237
Applicant Contact Weida Zhan
Correspondent
Shanghai Mediworks Precision Instruments Co. , Ltd.
Zone A, 2nd Floor, # 69, Lane
1985, Chunshen Rd. Minhang District,
Shanghai,  CN 200237
Correspondent Contact Weida Zhan
Regulation Number886.1930
Classification Product Code
HKY  
Date Received08/14/2014
Decision Date 04/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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