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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name arthroscope
510(k) Number K113352
Device Name TRANSCORP SPINAL ACCESS SYSTEM
Original Applicant
TRANSCORP, INC.
1000 100th st. sw
suite f
byron center,  MI  49315
Original Contact andrew rodenhouse
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/14/2011
Decision Date 04/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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