FDA 510(k) Application Details - K973038

Device Classification Name Device, Anti-Snoring

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510(K) Number K973038
Device Name Device, Anti-Snoring
Applicant DISTAR, INC.
214 WEST CORK ST.
WINCHESTER, VA 22601-4136 US
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Contact STEPHEN A BROWN
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 08/14/1997
Decision Date 11/12/1997
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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