FDA 510(k) Application Details - K982515

Device Classification Name	Laparoscope, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K982515
Device Name	Laparoscope, Gynecologic (And Accessories)
Applicant	WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH RUDOLF-DIESEL-RING 20 SAUERLACH D-82054 DE Other 510(k) Applications for this Company
Contact	HORST SEMM 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	07/20/1998
Decision Date	01/19/1999
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