FDA 510(k) Application Details - K030603

Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental

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510(K) Number K030603
Device Name Handpiece, Contra- And Right-Angle Attachment, Dental
Applicant PAC-DENT INTERNATIONAL (SUZHOU), LTD.
125 BINHE ROAD
NEW DISTRICT OF SUZHOU CITY
JIANGSU PROVINCE 215011 CN
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Contact XU WANG
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Regulation Number 872.4200

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Classification Product Code EGS
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Date Received 02/25/2003
Decision Date 04/14/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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