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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K083202
Device Name COMBOCARE 2000
Applicant
Xanacare Technologies, LLC
13605 W. 7th Ave.
Golden,  CO  80401
Applicant Contact ROBERT N CLARK
Correspondent
Xanacare Technologies, LLC
13605 W. 7th Ave.
Golden,  CO  80401
Correspondent Contact ROBERT N CLARK
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
ILY   ISA  
Date Received10/30/2008
Decision Date 12/15/2008
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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