FDA 510(k) Application Details - K193444

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K193444
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	Dr. August Wolff GmbH & Co. KG Arzneimittel Sudbrackstrasse 56 Bielefeld D-33611 DE Other 510(k) Applications for this Company
Contact	Thomas Flototto Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	NUC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2019
Decision Date	12/04/2020
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	N
Expedited Review