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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 K062947
Device Name HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES
Applicant
Peng Lim Enterprise Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Applicant Contact Ke-Min Jen
Correspondent
Peng Lim Enterprise Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Correspondent Contact Ke-Min Jen
Regulation Number872.4200
Classification Product Code
EFB  
Date Received09/28/2006
Decision Date 12/14/2006
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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