FDA 510(k) Application Details - K000212

Device Classification Name	Instrument, Manual, General Obstetric-Gynecologic   More FDA Info for this Device
510(K) Number	K000212
Device Name	Instrument, Manual, General Obstetric-Gynecologic
Applicant	KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE CULVER CITY, CA 90230-7600 US Other 510(k) Applications for this Company
Contact	KEVIN KENNAN Other 510(k) Applications for this Contact
Regulation Number	884.4520   More FDA Info for this Regulation Number
Classification Product Code	KOH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2000
Decision Date	04/21/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review