Device Classification Name	System, Test, Blood Glucose, Over The Counter
510(k) Number	K093712
Device Name	FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM
Applicant	Taidoc Technology Corporation 6f, # 127, Wugong 2nd Rd. Wugu Township New Taipei City,  TW 248
Applicant Contact	NICKY PAN
Correspondent	Taidoc Technology Corporation 6f, # 127, Wugong 2nd Rd. Wugu Township New Taipei City,  TW 248
Correspondent Contact	NICKY PAN
Regulation Number	862.1345
Classification Product Code	NBW
Subsequent Product Code	CGA
Date Received	12/02/2009
Decision Date	02/19/2010
Decision	Substantially Equivalent (SESE)
Regulation Medical Specialty	Clinical Chemistry
510k Review Panel	Clinical Chemistry
Summary	Summary
FDA Review	Decision Summary
Type	Special
Reviewed by Third Party	No
Combination Product	No
Predetermined Change Control Plan Authorized	No