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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 K142248
Device Name Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope
Applicant
Urologix, Inc.
14405 21st Ave. N
Plymouth,  MN  55447
Applicant Contact Georgiann Keyport
Correspondent
Urologix, Inc.
14405 21st Ave. N
Plymouth,  MN  55447
Correspondent Contact Georgiann Keyport
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
KNS  
Date Received08/14/2014
Decision Date 02/20/2015
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
Predetermined Change
Control Plan Authorized		 No
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