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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K962132
Device Name SILKON STAINLESS STEEL CABLE SYSTEM
Applicant
Osteonics Corp.
2 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact CHARLES RYAN
Correspondent
Osteonics Corp.
2 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact CHARLES RYAN
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received06/03/1996
Decision Date 08/08/1996
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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