FDA 510(k) Application Details - K973849

Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue

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510(K) Number K973849
Device Name Fastener, Fixation, Biodegradable, Soft Tissue
Applicant HOGAN & HARTSON
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact JONATHAN S KAHAN
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Regulation Number 888.3030

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Classification Product Code MAI
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Date Received 10/08/1997
Decision Date 01/06/1998
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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