FDA 510(k) Application Details - K961574

Device Classification Name Scraper, Tongue

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510(K) Number K961574
Device Name Scraper, Tongue
Applicant U.S. DENTEK CORP.
1320 INDUSTRIAL AVE.
PETALUMA, CA 94952 US
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Contact JOHN JANSHEKI
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Regulation Number 872.6855

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Classification Product Code LCN
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Date Received 04/23/1996
Decision Date 06/10/1996
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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