FDA 510(k)

TEMP. REPAIR KIT-DUAL LUMEN CATHETER

K-Number: K831587 · 1983-10-19

ApplicantNorton Performance Plastics Corp.

Decision Date1983-10-19

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

TEMP. REPAIR KIT-DUAL LUMEN CATHETER 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 1983-10-19 under 510(k) number K831587. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMP. REPAIR KIT-DUAL LUMEN CATHETER?

TEMP. REPAIR KIT-DUAL LUMEN CATHETER is a medical device that received FDA 510(k) clearance on 1983-10-19. The listed applicant is Norton Performance Plastics Corp.. The 510(k) number is K831587.

When did TEMP. REPAIR KIT-DUAL LUMEN CATHETER receive FDA 510(k) clearance?

TEMP. REPAIR KIT-DUAL LUMEN CATHETER received FDA 510(k) clearance on 1983-10-19, under 510(k) number K831587.

Who is the listed applicant for TEMP. REPAIR KIT-DUAL LUMEN CATHETER?

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 TEMP. REPAIR KIT-DUAL LUMEN CATHETER?

The FDA product code for TEMP. REPAIR KIT-DUAL LUMEN CATHETER is LJS.

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Other records listing Norton Performance Plastics Corp. as applicant

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Related Devices (Code: LJS)

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Official Source

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