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510(k) K222969

Device
FERTI-LILY Conception Cup
Applicant
Rosesta Medical BV
510(k) number
K222969
Product code
HDR
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-23
Date received
2022-09-27
Regulation
884.5250
Classification name
Cap, Cervical
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stal Robert
Address
Mr. Treublaan 7 I Amsterdam NL 1079DP 1079DP

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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