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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K102517
Device Name TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS
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
EFB  
Date Received09/02/2010
Decision Date 04/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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