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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
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