FDA 510(k)

NORTON MANIFOLD

K-Number: K820864 · 1982-04-15

ApplicantNorton Performance Plastics Corp.

Decision Date1982-04-15

Product CodeDTL

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NORTON MANIFOLD is the device name listed in this FDA 510(k) record. The listed applicant is Norton Performance Plastics Corp.. It received FDA 510(k) clearance on 1982-04-15 under 510(k) number K820864. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTON MANIFOLD?

NORTON MANIFOLD is a medical device that received FDA 510(k) clearance on 1982-04-15. The listed applicant is Norton Performance Plastics Corp.. The 510(k) number is K820864.

When did NORTON MANIFOLD receive FDA 510(k) clearance?

NORTON MANIFOLD received FDA 510(k) clearance on 1982-04-15, under 510(k) number K820864.

Who is the listed applicant for NORTON MANIFOLD?

The FDA 510(k) record lists Norton Performance Plastics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORTON MANIFOLD?

The FDA product code for NORTON MANIFOLD is DTL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Norton Performance Plastics Corp. as applicant

K853791NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 K852914ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION K851299CORRECT FLO K842858FLUID ADMINISTRATION LINE W/SPIKE 14-923 K841828CENTRAL VENOUS CATHETER W/BIG-GARD K840240MICROFUSE INTRAVENOUS CATHETER SET

View all 39 devices →

Related Devices (Code: DTL)

K131124COLIGNJilin Coronado Medical , Ltd.K123448AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVEMedtronic, Inc.K122811CONNECTOR COMPONENTS WITH BALANCE BIOSURFACEMedtronic, Inc.K122301GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVEVascular Solutions Zerusa , Ltd.K120069MEDLINE STOPCOCK AND MANIFOLDMedline Industries, Inc.K113148E-PASSSynexmed(Shenzhen)Company Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.