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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, Metallic
510(k) Number K003618
Device Name WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014
Applicant
Whiteside Biomechanics, Inc.
12634 Olive Blvd.
Creve Coeur,  MO  63141
Applicant Contact DEBRA MEYER
Correspondent
Whiteside Biomechanics, Inc.
12634 Olive Blvd.
Creve Coeur,  MO  63141
Correspondent Contact DEBRA MEYER
Regulation Number888.3010
Classification Product Code
NDD  
Date Received11/22/2000
Decision Date 05/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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