FDA 510(k) Application Details - K992480

Device Classification Name	Laparoscope, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K992480
Device Name	Laparoscope, Gynecologic (And Accessories)
Applicant	MEDIFIX, INC. 8727 NARRAGANSETT MORTON GROVE, IL 60053-0000 US Other 510(k) Applications for this Company
Contact	GEORGE ALBULESCU 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	07/26/1999
Decision Date	09/23/1999
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