510(k) K770299

Device: TYGON M-60/TYGON M-70
Applicant: Norton Performance Plastics Corp.
510(k) number: K770299
Product code: FID
Decision: Substantially Equivalent (SESE)
Decision date: 1977-03-16
Date received: 1977-02-14
Regulation: 876.5820
Classification name: Tubing, Dialysate
Medical specialty: Gastroenterology, Urology
Review panel: Gastroenterology, Urology
Device class: 2
Clearance type: Traditional
Third party reviewed: N

Applicant Contact#

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

FDA Registration Numbers#

1424263
1932668

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FID#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K022068	TUBING, DIALYSATE (AND CONNECTOR)	Molded Products, Inc.	2002-09-23
K010712	DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES	Molded Products, Inc.	2001-09-27