FDA 510(k) Application Details - K180429

Device Classification Name	Culdoscope (And Accessories)   More FDA Info for this Device
510(K) Number	K180429
Device Name	Culdoscope (And Accessories)
Applicant	CooperSurgical, Inc. 95 Corporate Dr Trumbull, CT 06611 US Other 510(k) Applications for this Company
Contact	Roaida Johnson 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	02/16/2018
Decision Date	03/14/2018
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