FDA 510(k) Application Details - K071754

Device Classification Name	Dilator, Vaginal   More FDA Info for this Device
510(K) Number	K071754
Device Name	Dilator, Vaginal
Applicant	KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE CULVER CITY, CA 90230-7600 US Other 510(k) Applications for this Company
Contact	CRYSTAL DIZOL Other 510(k) Applications for this Contact
Regulation Number	884.3900   More FDA Info for this Regulation Number
Classification Product Code	HDX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2007
Decision Date	01/07/2009
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