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FDA 510(k) Application Details - K071061
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K071061
Device Name
Staple, Implantable
Applicant
SORBX, LLC
PO BOX 3614
PONTE VEDRA BEACH, FL 32004 US
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Contact
MARY LEE WILLETS
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
04/16/2007
Decision Date
05/16/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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