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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K022433
Device Name NEOGENESYS 2K
Applicant
Sanexas Intl. GmbH
200 NE Mulberry
Lee'S Summit,  MO  64086
Applicant Contact GENE KELLY
Correspondent
Sanexas Intl. GmbH
200 NE Mulberry
Lee'S Summit,  MO  64086
Correspondent Contact GENE KELLY
Regulation Number882.5890
Classification Product Code
LIH  
Subsequent Product Codes
GZJ   IPF  
Date Received07/25/2002
Decision Date 01/24/2003
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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