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FDA 510(k) Application Details - K020343
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K020343
Device Name
Staple, Implantable
Applicant
POWER MEDICAL INTERVENTIONS, INC.
110 UNION SQUARE DR.
NEW HOPE, PA 18938-1364 US
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Contact
LAURENCE A POTTER
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
02/01/2002
Decision Date
04/10/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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