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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K111000
Device Name PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
Applicant
Parcus Medical, LLC
839 S. Neenah Ave.
Sturgeon Bay,  WI  54235
Applicant Contact BARTON BRACY
Correspondent
Parcus Medical, LLC
839 S. Neenah Ave.
Sturgeon Bay,  WI  54235
Correspondent Contact BARTON BRACY
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MBI  
Date Received04/11/2011
Decision Date 07/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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