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510(k) K915144

DEXTER HAND EVALUATION AND THERAPY SYSTEM by Cedars Medical Center — Product Code IKK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1992
Date Received
November 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Isokinetic Testing And Evaluation
Device Class
Class II
Regulation Number
890.1925
Review Panel
PM
Submission Type

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