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510(k) K152308

Sensor Medical Single Use Tonometer Prism by Sensor Medical Technology, LLC — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2015
Date Received
August 14, 2015
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

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