FDA 510(k) Application Details - K980166

Device Classification Name	Laparoscope, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K980166
Device Name	Laparoscope, Gynecologic (And Accessories)
Applicant	CUDA PRODUCTS CO. 6000 POWERS AVE. JACKSONVILLE, FL 32217 US Other 510(k) Applications for this Company
Contact	KIM REEK Other 510(k) Applications for this Contact
Regulation Number	884.1720   More FDA Info for this Regulation Number
Classification Product Code	HET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/1998
Decision Date	04/01/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review