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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, recombinant technology
510(k) Number K122487
Device Name BIOFIBER SYTURE
Original Applicant
TORNIER, INC.
10801 nesbitt avenue
bloomington,  MN  55437
Original Contact lael j pickett
Regulation Number878.4494
Classification Product Code
NWJ  
Date Received08/15/2012
Decision Date 09/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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