FDA 510(k) Application Details - K052572

Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue

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510(K) Number K052572
Device Name Fastener, Fixation, Nondegradable, Soft Tissue
Applicant THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS, FL 33410 US
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Contact WILLIAM CONETY
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Regulation Number 888.3040

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Classification Product Code MBI
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Date Received 09/19/2005
Decision Date 12/05/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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