FDA 510(k) Application Details - K112196

Device Classification Name	More FDA Info for this Device
510(K) Number	K112196
Device Name	OCTOTMPORT
Applicant	DALIM SURGNET CORPORATION 325 N PUENTE ST. UNIT B BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	APRIL LEE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2011
Decision Date	09/14/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review