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FDA 510(k) Application Details - K182661
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
510(K) Number
K182661
Device Name
Device, Anti-Snoring
Applicant
Sketchpad Innovations LLC
10767 Glendover Ln.
San Diego, CA 92126 US
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Contact
Phillip "Sonnie" Bocala
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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
09/25/2018
Decision Date
02/13/2019
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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