FDA 510(k) Application Details - K962493

Device Classification Name	Endoscopic Tissue Approximation Device   More FDA Info for this Device
510(K) Number	K962493
Device Name	Endoscopic Tissue Approximation Device
Applicant	AESCULAP, INC. 1000 GATEWAY BLVD. SOUTH SAN FRANCISCO, CA 94080 US Other 510(k) Applications for this Company
Contact	MARY ELLEN HOLDEN 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	06/26/1996
Decision Date	09/11/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review