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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 K021249
Device Name SURGASSIST FLEXSHAFT 2, MODEL FS2 14
Applicant
POWER MEDICAL INTERVENTIONS, INC.
110 UNION SQUARE DR.
NEW HOPE,  PA  18938 -1364
Applicant Contact BARBARA J WHITMAN
Correspondent
POWER MEDICAL INTERVENTIONS, INC.
110 UNION SQUARE DR.
NEW HOPE,  PA  18938 -1364
Correspondent Contact BARBARA J WHITMAN
Regulation Number878.4750
Classification Product Code
GDW  
Date Received04/19/2002
Decision Date 05/15/2002
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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