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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K061113
Device Name ORTHOMON
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 Number882.1870
Classification Product Code
GWF  
Subsequent Product Code
IKN  
Date Received04/21/2006
Decision Date 05/23/2006
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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