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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 K120942
Model 10511, 10511T, 10521, 10521T, 10517, 10517T, 10522, 10522T, 10524, 10424T, 10518, 10518T, 10523, 10523T, 10525, 10525T
Device Name PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC
Original Applicant
PARCUS MEDICAL, LLC
839 south neenah ave.
sturgeon bay,  WI  54235
Original Contact paul vagts
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/29/2012
Decision Date 04/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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