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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 K020719
Device Name SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES
Applicant
Power Medical Interventions, Inc.
4 B E. Bridge St.
New Hope,  PA  18938
Applicant Contact BARBARA J WHITMAN
Correspondent
Power Medical Interventions, Inc.
4 B E. Bridge St.
New Hope,  PA  18938
Correspondent Contact BARBARA J WHITMAN
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/05/2002
Decision Date 05/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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