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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K101139
Device Name PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
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 Number876.4300
Classification Product Code
KNS  
Subsequent Product Code
GEI  
Date Received04/22/2010
Decision Date 05/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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