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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Cervical
510(k) Number K222969
Device Name FERTI-LILY Conception Cup
Applicant
Rosesta Medical BV
Mr. Treublaan 7 I
Amsterdam,  NL 1079DP
Applicant Contact Stal Robert
Correspondent
CRA Solutions, Inc.
6250 Coral Ridge Dr. Suite 100
Coral Springs,  FL  33076
Correspondent Contact Jill Matzat
Regulation Number884.5250
Classification Product Code
HDR  
Date Received09/27/2022
Decision Date 06/23/2023
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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