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FDA 510(k) Application Details - K071023
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K071023
Device Name
Staple, Implantable
Applicant
REACH SURGICAL, INC
4480 LAKE FOREST DR.
SUITE 414
CINCINNATI, OH 45242 US
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Contact
RICH GRANT
Other 510(k) Applications for this Contact
Regulation Number
878.4750
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Classification Product Code
GDW
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More FDA Info for this Product Code
Date Received
04/11/2007
Decision Date
08/28/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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