FDA 510(k) Application Details - K203567

Device Classification Name Saliva, Artificial

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510(K) Number K203567
Device Name Saliva, Artificial
Applicant The Procter & Gamble Company
1 Procter & Gamble Plaza
Cincinnati, OH 45202 US
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Contact Brenda S. Fuentes
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Regulation Number 000.0000

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Classification Product Code LFD
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Date Received 12/07/2020
Decision Date 04/05/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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