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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 K232040
Device Name Gynatrof
Applicant
Tyros Biopharma, Inc.
4702 Louis-B.-Mayer
Suite 305
Laval,  CA H7P 0L9
Applicant Contact Anthony Gouvoussis
Correspondent
QUARAS, LLC
2101 Camino Rey
Fullerton,  CA  92833
Correspondent Contact Roshana Ahmed
Regulation Number884.5300
Classification Product Code
NUC  
Date Received07/10/2023
Decision Date 03/01/2024
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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