FDA 510(k) Application Details - K242913

Device Classification Name Varnish, Cavity

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510(K) Number K242913
Device Name Varnish, Cavity
Applicant Jasberry Healthcare Private Limited
162 Model Town
Kapurthala 144401 IN
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Contact Balwant Rai
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Regulation Number 872.3260

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Classification Product Code LBH
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Date Received 09/24/2024
Decision Date 11/22/2024
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 K242913


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