FDA 510(k) Application Details - K974138

Device Classification Name	Electrocautery, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K974138
Device Name	Electrocautery, Gynecologic (And Accessories)
Applicant	A & A MEDICAL, INC. 4100 NINE MCFARLAND DR., #B ALPHARETTA, GA 30201 US Other 510(k) Applications for this Company
Contact	JIHAD MANSOUR Other 510(k) Applications for this Contact
Regulation Number	884.4120   More FDA Info for this Regulation Number
Classification Product Code	HGI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/1997
Decision Date	01/30/1998
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