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510(k) K203850

CATS®-D Tonometer Prism by Cats Tonometer, LLC — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2021
Date Received
December 31, 2020
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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