510(k) K801680

Device: Beta-cap Ii Adapter
Applicant: QUINTON, INC.
510(k) number: K801680
Product code: GCE
Decision: Substantially Equivalent (SESE)
Decision date: 1980-08-04
Date received: 1980-07-22
Regulation: 878.4200
Classification name: Adaptor, Catheter
Medical specialty: General, Plastic Surgery
Review panel: General, Plastic Surgery
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCE#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K901715	KLEIN CORK(TM)	Jeff Klein Surgical, Inc.	1990-05-11
K901716	KLEIN CONNECTOR(TM)	Jeff Klein Surgical, Inc.	1990-05-11
K855039	MEDIFLEX INJECTION CAP	Mediflex Intl.	1986-01-24