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FDA 510(k) Application Details - K223901
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
510(K) Number
K223901
Device Name
Device, Anti-Snoring
Applicant
Apnea Sciences Coporation
27121 Aliso Creek Road, Bldg 140
Aliso Viejo, CA 92656 US
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Contact
James Fallon
Other 510(k) Applications for this Contact
Regulation Number
872.5570
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Classification Product Code
LRK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/28/2022
Decision Date
09/01/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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