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FDA 510(k) Application Details - K070178
Device Classification Name
Fastener, Fixation, Biodegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K070178
Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Applicant
AESCULAP IMPLANT SYSTEM, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact
MATTHEW M HULL
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
01/19/2007
Decision Date
04/30/2007
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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