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FDA 510(k) Application Details - K103704
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
510(K) Number
K103704
Device Name
Device, Anti-Snoring
Applicant
ZEPHYR SLEEP TECHNOLOGIES INC
2513 17 ST SE
CALGARY; ALBERTA T2L 2K7 CA
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Contact
SABINA BRUCHLMANN
Other 510(k) Applications for this Contact
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
12/20/2010
Decision Date
03/23/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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