FDA 510(k) Application Details - K233563

Device Classification Name

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510(K) Number K233563
Device Name Navident
Applicant ClaroNav Inc.
1140 Sheppard Avenue West - Unit 10
Toronto M3K2A2 CA
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Contact Carly Desmond
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Regulation Number

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Classification Product Code PLV
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Date Received 11/06/2023
Decision Date 07/25/2024
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

FDA Source Information for K233563


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