FDA 510(k) Application Details - K231663

Device Classification Name Device, Anti-Snoring

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510(K) Number K231663
Device Name Device, Anti-Snoring
Applicant Innovative Health Technologies (NZ), Ltd
229 Mopray Pl
Dunedin 9016 NZ
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Contact Chapman Philip
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 06/07/2023
Decision Date 09/18/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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