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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 K043442
Device Name STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
Applicant
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact JEAN SHEPPARD
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NEIL E DEVINE
Regulation Number882.4725
Classification Product Code
GXI  
Date Received12/14/2004
Decision Date 05/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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