FDA 510(k) Application Details - K240619

Device Classification Name

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510(K) Number K240619
Device Name e-SDF
Applicant Kids-e-Dental LLP
411- Akruti Arcade JP road, Azad nagar, Opp A.H. Wadia
school, Andheri west
Mumbai 400053 IN
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Contact Mukul Jain
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Regulation Number

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Classification Product Code PHR
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Date Received 03/05/2024
Decision Date 03/06/2024
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 Y
Expedited Review

FDA Source Information for K240619


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