FDA 510(k)

NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000

K-Number: K853791 · 1985-12-09

ApplicantNorton Performance Plastics Corp.

Decision Date1985-12-09

Product CodeDTR

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 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 1985-12-09 under 510(k) number K853791. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000?

NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 is a medical device that received FDA 510(k) clearance on 1985-12-09. The listed applicant is Norton Performance Plastics Corp.. The 510(k) number is K853791.

When did NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 receive FDA 510(k) clearance?

NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 received FDA 510(k) clearance on 1985-12-09, under 510(k) number K853791.

Who is the listed applicant for NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000?

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 CARDIOPLEGIC QUICK COOLING COIL 421738-000?

The FDA product code for NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 is DTR.

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Other records listing Norton Performance Plastics Corp. as applicant

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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.