FDA 510(k) Application Details - K971277

Device Classification Name	Instrument, Manual, Specialized Obstetric-Gynecologic   More FDA Info for this Device
510(K) Number	K971277
Device Name	Instrument, Manual, Specialized Obstetric-Gynecologic
Applicant	TALON MEDICAL, LTD. 18160 HWY., 281 NORTH,#108-200 SAN ANTONIO, TX 78232 US Other 510(k) Applications for this Company
Contact	DAVID COCKE Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	KNA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/1997
Decision Date	05/20/1997
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