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FDA 510(k) Application Details - K223624
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
510(K) Number
K223624
Device Name
Device, Anti-Snoring
Applicant
Island Dental Lab, Inc dba Emerald Dental
76 S. Central Avenue #1D
Valley Stream, NY 11580 US
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Contact
Israel Wettenstein
Other 510(k) Applications for this Contact
Regulation Number
872.5570
More FDA Info for this Regulation Number
Classification Product Code
LRK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/05/2022
Decision Date
05/10/2023
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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