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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K033198
Device Name APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
Applicant
Apoza Enterprise Co., Ltd.
6 F,#657, Chuang Cheng Rd.
Hsin-Chuang City
Taipei Hsien,  TW 242
Applicant Contact SHIH MIN-TEH
Correspondent
Apoza Enterprise Co., Ltd.
6 F,#657, Chuang Cheng Rd.
Hsin-Chuang City
Taipei Hsien,  TW 242
Correspondent Contact SHIH MIN-TEH
Regulation Number872.4850
Classification Product Code
ELC  
Date Received10/02/2003
Decision Date 04/30/2004
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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