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510(k) K142263

Applanation Tonometer by Shanghai Mediworks Precision Instruments Co. , Ltd. — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2016
Date Received
August 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Manual
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

Other clearances by Shanghai Mediworks Precision Instruments Co. , Ltd.

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