FDA 510(k) Application Details - K980075

Device Classification Name Scraper, Tongue

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510(K) Number K980075
Device Name Scraper, Tongue
Applicant AMERICAN DENTRONICS, INC.
1350 E. FLAMINGO RD. #573
LAS VEGAS, NV 89119 US
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Contact RONALD K MURAYAMA
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Regulation Number 872.6855

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Classification Product Code LCN
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Date Received 01/08/1998
Decision Date 03/04/1998
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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