510(k) K942677

Device: GEENEN/ZEBRA GUIDELINES
Applicant: Boston Scientific Corp
510(k) number: K942677
Product code: FDE
Decision: Substantially Equivalent (SESE)
Decision date: 1994-07-21
Date received: 1994-06-07
Regulation: 876.1500
Classification name: Laparoscopy Kit
Medical specialty: Gastroenterology, Urology
Review panel: Gastroenterology, Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: JOSEPH J CURTIS
Address: 400, 480, 610, 650 Pleasant St. Watertown MA US 02172 02172

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FDE#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K955717	ENDOSCOPE INTRODUCER KIT	Mitsubishi Cable America, Inc.	1996-04-18
K950924	ASLAN KNOT PUSHER	Aslan Medical Technologies, Ltd.	1995-03-14
K912443	CANDELA INTRODUCER SHEATH SYSTEM	Candela Laser Corp.	1991-08-16