FDA 510(k) Application Details - K955822

Device Classification Name Device, Anti-Snoring

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510(K) Number K955822
Device Name Device, Anti-Snoring
Applicant UNIV. DENTAL ASSOC. DEPARTMENT OF ORTHODONTICS
140 SQUIRE HALL
BUFFALO, NY 14214 US
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Contact STEPHEN P WARUNEK
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 12/26/1995
Decision Date 03/20/1996
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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