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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 K073226
Device Name CINCH KNOTLESS FIXATION IMPLANT SYSTEM
Applicant
C2M MEDICAL, INC.
3463 MAGIC DRIVE
SUITE 320
SAN ANTONIO,  TX  78229
Applicant Contact GABRIELE G NIEDERAUER
Correspondent
C2M MEDICAL, INC.
3463 MAGIC DRIVE
SUITE 320
SAN ANTONIO,  TX  78229
Correspondent Contact GABRIELE G NIEDERAUER
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/15/2007
Decision Date 12/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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