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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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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