FDA 510(k) Application Details - K972488

Device Classification Name	Laparoscope, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K972488
Device Name	Laparoscope, Gynecologic (And Accessories)
Applicant	KARL STORZ ENDOSCOPY 600 CORPORATE POINTE CULVER CITY, CA 90230-7600 US Other 510(k) Applications for this Company
Contact	MARLENA A PIERCY 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	07/02/1997
Decision Date	01/22/1998
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