FDA 510(k) Application Details - K954982

Device Classification Name	Endoscope, Fetal Blood Sampling (And Accessories)   More FDA Info for this Device
510(K) Number	K954982
Device Name	Endoscope, Fetal Blood Sampling (And Accessories)
Applicant	KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE CULVER CITY, CA 90230-7600 US Other 510(k) Applications for this Company
Contact	MARIKA ANDERSON Other 510(k) Applications for this Contact
Regulation Number	884.1660   More FDA Info for this Regulation Number
Classification Product Code	HGK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/1995
Decision Date	07/17/1996
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