FDA 510(k) Application Details - K040817

Device Classification Name	Speculum, Vaginal, Nonmetal   More FDA Info for this Device
510(K) Number	K040817
Device Name	Speculum, Vaginal, Nonmetal
Applicant	ADVANCED UROLOGICAL DEVELOPMENTS 485 DARTMOUTH AVENUE SAN CARLOS, CA 94070 US Other 510(k) Applications for this Company
Contact	GERMAN BORODULIN Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2004
Decision Date	06/22/2004
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