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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 K071708
Device Name I45, I45S, I60, AND I60S
Applicant
POWER MEDICAL INTERVENTIONS, INC.
2021 CABOT BLVD.
LANGHORNE,  PA  19047
Applicant Contact BARBARA J WHITMAN
Correspondent
POWER MEDICAL INTERVENTIONS, INC.
2021 CABOT BLVD.
LANGHORNE,  PA  19047
Correspondent Contact BARBARA J WHITMAN
Regulation Number878.4750
Classification Product Code
GDW  
Date Received06/21/2007
Decision Date 09/27/2007
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
Recalls CDRH Recalls
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