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510(k) K003618

WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 by Whiteside Biomechanics, Inc. — Product Code NDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2001
Date Received
November 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cerclage, Fixation, Metallic
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

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