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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 K082464
Device Name PROSTIVA RF THERAPY HAND PIECE, MODEL 8929
Applicant
Medtronic, Inc.
710 Medtronic Pkwy. NE
Minneapolis,  MN  55432
Applicant Contact JEANMARIE SALES
Correspondent
Medtronic, Inc.
710 Medtronic Pkwy. NE
Minneapolis,  MN  55432
Correspondent Contact JEANMARIE SALES
Regulation Number876.4300
Classification Product Code
KNS  
Subsequent Product Code
GEI  
Date Received08/27/2008
Decision Date 10/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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