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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K213220
Device Name Revaree Plus Vaginal Suppositories
Applicant
Farma-Derma S.R.L.
Via Dell'Artigiano 6-8
Sala Bolognese,  IT 40010
Applicant Contact Mara Calzolari
Correspondent
Farma-Derma S.R.L.
Via Dell'Artigiano 6-8
Sala Bolognese,  IT 40010
Correspondent Contact Mara Calzolari
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/29/2021
Decision Date 06/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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