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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 K012809
Device Name SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45
Applicant
POWER MEDICAL INTERVENTIONS, INC.
4 B EAST BRIDGE ST.
NEW HOPE,  PA  18938
Applicant Contact LAURENCE A POTTER
Correspondent
POWER MEDICAL INTERVENTIONS, INC.
4 B EAST BRIDGE ST.
NEW HOPE,  PA  18938
Correspondent Contact LAURENCE A POTTER
Regulation Number878.4750
Classification Product Code
GDW  
Date Received08/22/2001
Decision Date 10/26/2001
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
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