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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 K052822
Device Name DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202
Applicant
Thunder Tiger Corp.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Applicant Contact KE MIN JEN
Correspondent
Thunder Tiger Corp.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Correspondent Contact KE MIN JEN
Regulation Number872.4200
Classification Product Code
EFB  
Date Received10/04/2005
Decision Date 01/20/2006
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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