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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 K030653
Device Name SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS
Applicant
Power Medical Interventions, Inc.
110 Union Square Dr.
New Hope,  PA  18938 -1364
Applicant Contact BABARA J WHITMAN
Correspondent
Power Medical Interventions, Inc.
110 Union Square Dr.
New Hope,  PA  18938 -1364
Correspondent Contact BABARA J WHITMAN
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/03/2003
Decision Date 03/31/2003
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
Predetermined Change
Control Plan Authorized		 No
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