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FDA 510(k) Application Details - K110728
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K110728
Device Name
Staple, Implantable
Applicant
EASYLAP LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS, FL 34134 US
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Contact
PAUL DRYDEN
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
03/16/2011
Decision Date
06/08/2011
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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