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FDA 510(k) Application Details - K071560
Device Classification Name
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
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510(K) Number
K071560
Device Name
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Applicant
VENTUS MEDICAL, INC.
1171 BARROILHET DRIVE
HILLSBOROUGH, CA 94010 US
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Contact
CINDY DOMECUS
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Regulation Number
872.5570
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Classification Product Code
OHP
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More FDA Info for this Product Code
Date Received
06/07/2007
Decision Date
02/08/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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