FDA 510(k) Application Details - K033728

Device Classification Name	Culdoscope (And Accessories)   More FDA Info for this Device
510(K) Number	K033728
Device Name	Culdoscope (And Accessories)
Applicant	KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE 5TH FLOOR CULVER CITY, CA 90230-7600 US Other 510(k) Applications for this Company
Contact	YVONNE FERNANDEZ 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	11/28/2003
Decision Date	02/27/2004
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