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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K233846
Device Name Vitrification Solution Set and Warming Solution Set
Applicant
Ecmpc, LLC
22751 Professional Dr.
Suite 220
Kingwood,  CA  77339
Applicant Contact Jose Gaytan Melicoff
Correspondent
Emergo by UL
2500 Bee Caves Rd. Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Sarah Fitzgerald
Regulation Number884.6180
Classification Product Code
MQL  
Date Received12/04/2023
Decision Date 08/27/2024
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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