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FDA 510(k) Application Details - K053492
Device Classification Name
Fastener, Fixation, Biodegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K053492
Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Applicant
BIODUCT, LLC
3201 STELLHORN ROAD
FORT WAYNE, IN 46815 US
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Contact
HERB SCHWARTZ
Other 510(k) Applications for this Contact
Regulation Number
888.3030
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Classification Product Code
MAI
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More FDA Info for this Product Code
Date Received
12/15/2005
Decision Date
04/12/2007
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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