FDA 510(k) Application Details - K070315

Device Classification Name	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)   More FDA Info for this Device
510(K) Number	K070315
Device Name	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant	LINA MEDICAL APS 1289 N. FORDHAM BLVD. SUITE A-128 CHAPEL HILL, NC 27517 US Other 510(k) Applications for this Company
Contact	WALT BRITTLE Other 510(k) Applications for this Contact
Regulation Number	884.4160   More FDA Info for this Regulation Number
Classification Product Code	KNF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2007
Decision Date	10/30/2007
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