FDA 510(k) Application Details - K023843

Device Classification Name	Endoscopic Tissue Approximation Device   More FDA Info for this Device
510(K) Number	K023843
Device Name	Endoscopic Tissue Approximation Device
Applicant	OPUS MEDICAL, INC. 27127 CALLE ARROYO, SUITE 1924 SAN JUAN CAPISTRANO, CA 92675 US Other 510(k) Applications for this Company
Contact	JAMES W HART Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2002
Decision Date	02/14/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review