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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 K020352
Device Name SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE
Applicant
UNITED STATES SURGICAL
150 GLOVER AVE.
NORWALK,  CT  06856
Applicant Contact TINA RIDEOUT
Correspondent
UNITED STATES SURGICAL
150 GLOVER AVE.
NORWALK,  CT  06856
Correspondent Contact TINA RIDEOUT
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/04/2002
Decision Date 02/26/2002
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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