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510(k) K180839

AT 030 by Carl Zeiss Meditec, AG — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2018
Date Received
March 30, 2018
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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