FDA 510(k) Application Details - K061268

Device Classification Name	Laparoscope, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K061268
Device Name	Laparoscope, Gynecologic (And Accessories)
Applicant	USGI MEDICAL 1140 CALLE CORDILLERA SAN CLEMENTE, CA 92673 US Other 510(k) Applications for this Company
Contact	MARY LOU MOONEY Other 510(k) Applications for this Contact
Regulation Number	884.1720   More FDA Info for this Regulation Number
Classification Product Code	HET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2006
Decision Date	07/31/2006
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