FDA 510(k) Application Details - K983683

Device Classification Name Scraper, Tongue

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510(K) Number K983683
Device Name Scraper, Tongue
Applicant UNIK PRODUCTS, INC.
SALIBURY & CAMBRIA LLP
42 DELAWARE AVENUE, SUITE 300
BUFFALO, NY 14202 US
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Contact HARRY E WERNER
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Regulation Number 872.6855

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Classification Product Code LCN
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Date Received 10/20/1998
Decision Date 01/14/1999
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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