Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K233361

Sunny Cup and Applicator

510(k) number
K233361
Device name
Sunny Cup and Applicator
Applicant
Menstrual Mates DE · US
Product code
HHE — Cup, Menstrual
Decision date
2024-06-21
Date received
2023-09-29
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K233361.pdf

Official FDA record: K233361
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.