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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fastener, fixation, nondegradable, soft tissue
510(k) Number K113730
Model 10313, 10486, 10344, 10491
Device Name PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS
Original Applicant
PARCUS MEDICAL, LLC
839 south neenah ave.
sturgeon bay,  WI  54235
Original Contact paul vagts
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received12/19/2011
Decision Date 01/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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