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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 K123178
Device Name STRYKER VENOM ELECTRODES AND CANNULAE
Applicant
Stryker Instruments, Instruments Div.
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact CHRISTINA MCKEE
Correspondent
Stryker Instruments, Instruments Div.
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact CHRISTINA MCKEE
Regulation Number882.4725
Classification Product Code
GXI  
Date Received10/09/2012
Decision Date 03/28/2013
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
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