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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
Device Name PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS
Applicant
Parcus Medical, LLC
839 S. Neenah Ave.
Sturgeon Bay,  WI  54235
Applicant Contact PAUL VAGTS
Correspondent
Parcus Medical, LLC
839 S. Neenah Ave.
Sturgeon Bay,  WI  54235
Correspondent 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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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