FDA 510(k) Application Details - K053014

Device Classification Name Material, Impression

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510(K) Number K053014
Device Name Material, Impression
Applicant CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1980 HYDE PARK ROAD
LONDON, ONTARIO N6H 5L9 CA
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Contact JEANETTE SMITH
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Regulation Number 872.3660

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Classification Product Code ELW
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Date Received 10/26/2005
Decision Date 11/15/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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