FDA 510(k) Application Details - K964276

Device Classification Name	Culdoscope (And Accessories)   More FDA Info for this Device
510(K) Number	K964276
Device Name	Culdoscope (And Accessories)
Applicant	RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. VERNON HILLS, IL 60061 US Other 510(k) Applications for this Company
Contact	ROBERT L CASARSA 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	10/28/1996
Decision Date	11/25/1997
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