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FDA 510(k) Application Details - K231430
Device Classification Name
Dilator, Vaginal
More FDA Info for this Device
510(K) Number
K231430
Device Name
Dilator, Vaginal
Applicant
Plus EV Holdings dba Intimate Rose
1419 Murray Street
North Kansas City, MO 64116 US
Other 510(k) Applications for this Company
Contact
Aaron Wilt
Other 510(k) Applications for this Contact
Regulation Number
884.3900
More FDA Info for this Regulation Number
Classification Product Code
HDX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2023
Decision Date
06/07/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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