FDA 510(k) Application Details - K022313

Device Classification Name Staple, Implantable

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510(K) Number K022313
Device Name Staple, Implantable
Applicant POWER MEDICAL INTERVENTIONS, INC.
110 UNION SQUARE DR.
NEW HOPE, PA 18938-1364 US
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Contact BARBARA J WHITMAN
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Regulation Number 878.4750

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Classification Product Code GDW
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Date Received 07/17/2002
Decision Date 12/09/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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