• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Correspondent Contact ROBERT N CLARK
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
ISA   NHN  
Date Received04/22/2008
Decision Date 08/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-