FDA 510(k) Application Details - K103704

Device Classification Name Device, Anti-Snoring

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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
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Regulation Number 872.5570

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Classification Product Code LRK
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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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