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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K113380
Device Name PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
Applicant
MEDTRONIC INC.
7000 CENTRAL AVENUE NE
MINNEAPOLIS,  MN  55432 -3576
Applicant Contact THOMAS REICHEL
Correspondent
MEDTRONIC INC.
7000 CENTRAL AVENUE NE
MINNEAPOLIS,  MN  55432 -3576
Correspondent Contact THOMAS REICHEL
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
KNS  
Date Received11/16/2011
Decision Date 11/15/2012
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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