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FDA 510(k) Application Details - K170825
Device Classification Name
Device, Anti-Snoring
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510(K) Number
K170825
Device Name
Device, Anti-Snoring
Applicant
Apnea Sciences Corporation
27121 Aliso Creek Road, Bldg 140
Aliso Viejo, CA 92656 US
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Contact
James Fallon
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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
03/20/2017
Decision Date
08/18/2017
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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