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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K112305
Device Name VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES
Applicant
Thunder Tiger Corp.
# 7, 6th Rd.
Industry Park
Taichung,  TW 40755
Applicant Contact JO LEE
Correspondent
Thunder Tiger Corp.
# 7, 6th Rd.
Industry Park
Taichung,  TW 40755
Correspondent Contact JO LEE
Regulation Number872.4200
Classification Product Code
EGS  
Date Received08/11/2011
Decision Date 04/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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