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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K032701
Device Name SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)
Applicant
POWER MEDICAL INTERVENTIONS, INC.
110 UNION SQUARE DR.
NEW HOPE PA,  PA  18938
Applicant Contact BARBARA J WHITMAN
Correspondent
POWER MEDICAL INTERVENTIONS, INC.
110 UNION SQUARE DR.
NEW HOPE PA,  PA  18938
Correspondent Contact BARBARA J WHITMAN
Regulation Number878.4750
Classification Product Code
GDW  
Date Received09/02/2003
Decision Date 09/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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