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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 K030256
Device Name ISO-ELASTIC CERCLAGE SYSTEM
Applicant
Kinamed, Inc.
820 Flynn Rd.
Camarillo,  CA  93012
Applicant Contact VINEET SARIN
Correspondent
Kinamed, Inc.
820 Flynn Rd.
Camarillo,  CA  93012
Correspondent Contact VINEET SARIN
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received01/24/2003
Decision Date 10/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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