FDA 510(k) Application Details - K971887

Device Classification Name Scraper, Tongue

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510(K) Number K971887
Device Name Scraper, Tongue
Applicant HOFA LLC.
180 EAST 2100 SOUTH
SALT LAKE CITY, UT 84115 US
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Contact ZUDHIR NADKARNI
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Regulation Number 872.6855

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Classification Product Code LCN
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Date Received 05/21/1997
Decision Date 06/10/1997
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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