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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K032406
Device Name STRYKER RF ELECTRODES AND CANNULAE
Applicant
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact NICOLE PETTY
Correspondent
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact NICOLE PETTY
Regulation Number882.4725
Classification Product Code
GXI  
Subsequent Product Code
GXD  
Date Received08/04/2003
Decision Date 04/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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