FDA 510(k) Application Details - K993381

Device Classification Name Device, Anti-Snoring

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510(K) Number K993381
Device Name Device, Anti-Snoring
Applicant UNIVERSITY OF OTAGO
199 FIRE TOWER DR.
P.O. BOX 5111
TONAWANDA, NY 14151-5111 US
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Contact CHRISTINA M LAJOIE
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 10/07/1999
Decision Date 12/21/1999
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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