COMBOCARE 2000


Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K081141
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

Correspodent Contact robert n clark
Regulation Number 882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
ISA   NHN  
Date Received 04/22/2008
Decision Date 08/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No