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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K062996
Device Name DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
Applicant
Axon Systems, Inc.
400-2200 Oser Ave.
Hauppauge,  NY  11788
Applicant Contact HOWARD BAILIN
Correspondent
Axon Systems, Inc.
400-2200 Oser Ave.
Hauppauge,  NY  11788
Correspondent Contact HOWARD BAILIN
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received10/02/2006
Decision Date 01/12/2007
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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