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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 K191314
Device Name Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
Applicant
Chongqing Sunkingdom Medical Instrument Co., Ltd
1012, Block A of China Resource Center No.55 of XieJiaWan
JiuLongPo
Chongqing,  CN 400050
Applicant Contact Shulin Guo
Correspondent
Chongqing Sunkingdom Medical Instrument Co., Ltd
1012, Block A of China Resource Center No.55 of XieJiaWan
JiuLongPo
Chongqing,  CN 400050
Correspondent Contact Shulin Guo
Regulation Number886.1930
Classification Product Code
HKY  
Date Received05/15/2019
Decision Date 12/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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