FDA 510(k) Application Details - K232549

Device Classification Name

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510(K) Number K232549
Device Name NemoCast
Applicant Software Nemotec S.L.
Av. Juan Caramuel, 1
Leganes 28919 ES
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Contact Miguel del Moral
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Regulation Number

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Classification Product Code PNN
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Date Received 08/23/2023
Decision Date 11/21/2023
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 K232549


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