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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Nerve Locator
510(k) Number K123589
Device Name CADWELL DISPOSABLE PROBE HANDLE
Applicant
Cadwell
909 N Kellogg St.
Kennewick,  WA  99336
Applicant Contact CHRIS BOLKAN
Correspondent
Cadwell
909 N Kellogg St.
Kennewick,  WA  99336
Correspondent Contact CHRIS BOLKAN
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Codes
ETN   GXZ  
Date Received11/21/2012
Decision Date 03/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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