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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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More FDA Info for this Product Code
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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