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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 K122805
Device Name PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
Applicant
PARCUS MEDICAL, LLC
839 south neenah ave.
sturgeon bay,  WI  54235
Contact paul vagts
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/13/2012
Decision Date 02/05/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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