FDA 510(k) Application Details - K210947

Device Classification Name

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510(K) Number K210947
Device Name Navident
Applicant ClaroNav Inc
1140 Sheppard Avenue West Unit 10
Toronto M3K 2A2 CA
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Contact Tal Bresler Stramer
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Regulation Number

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Classification Product Code PLV
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Date Received 03/30/2021
Decision Date 06/27/2022
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 K210947


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