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FDA 510(k) Application Details - K211069
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
510(K) Number
K211069
Device Name
Device, Anti-Snoring
Applicant
Prismatik Dentalcraft, Inc.
2144 Michelson Drive
Irvine, CA 96212 US
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Contact
Herbert Schoenhoefer
Other 510(k) Applications for this Contact
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
04/12/2021
Decision Date
10/26/2021
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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