FDA 510(k) Application Details - K201086

Device Classification Name	Culdoscope (And Accessories)   More FDA Info for this Device
510(K) Number	K201086
Device Name	Culdoscope (And Accessories)
Applicant	CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 US Other 510(k) Applications for this Company
Contact	Kyle Hooper Other 510(k) Applications for this Contact
Regulation Number	884.1640   More FDA Info for this Regulation Number
Classification Product Code	HEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2020
Decision Date	05/21/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review