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510(k) Premarket Notification

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Device Classification Name system, isokinetic testing and evaluation
510(k) NumberK915846
Device NameBIODEX SYSTEM 2 AUTOPROGRAM
Applicant
BIODEX CORP.
20 ramsay rd.
p.o. box 702
shirley,  NY  11967
Contactclyde schlein
Regulation Number890.1925
Classification Product Code
IKK  
Date Received12/13/1991
Decision Date 01/13/1992
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
Statement/Summary/Purged Status Summary only
Type Traditional
Reviewed by Third Party No
Expedited Review
 
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