FDA 510(k) Application Details - K000199

Device Classification Name	Laparoscope, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K000199
Device Name	Laparoscope, Gynecologic (And Accessories)
Applicant	CORTEK ENDOSCOPY, INC. 501 W. COLFAX, SUITE B PALATINE, IL 60067 US Other 510(k) Applications for this Company
Contact	CORNEL M TOPALA 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	01/21/2000
Decision Date	04/13/2000
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