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FDA 510(k)

TYGON PAC-MONITORING LINES & FLUID ADMIN

K-Number: K770916 · 1977-06-17

ApplicantNorton Performance Plastics Corp.
Decision Date1977-06-17
Product CodeFMG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TYGON PAC-MONITORING LINES & FLUID ADMIN 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 1977-06-17 under 510(k) number K770916. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYGON PAC-MONITORING LINES & FLUID ADMIN?

TYGON PAC-MONITORING LINES & FLUID ADMIN is a medical device that received FDA 510(k) clearance on 1977-06-17. The listed applicant is Norton Performance Plastics Corp.. The 510(k) number is K770916.

When did TYGON PAC-MONITORING LINES & FLUID ADMIN receive FDA 510(k) clearance?

TYGON PAC-MONITORING LINES & FLUID ADMIN received FDA 510(k) clearance on 1977-06-17, under 510(k) number K770916.

Who is the listed applicant for TYGON PAC-MONITORING LINES & FLUID ADMIN?

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 TYGON PAC-MONITORING LINES & FLUID ADMIN?

The FDA product code for TYGON PAC-MONITORING LINES & FLUID ADMIN is FMG.

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Other records listing Norton Performance Plastics Corp. as applicant

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.

K853791NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000K852914ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSIONK851299CORRECT FLOK842858FLUID ADMINISTRATION LINE W/SPIKE 14-923K841828CENTRAL VENOUS CATHETER W/BIG-GARDK840240MICROFUSE INTRAVENOUS CATHETER SET

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Related Devices (Code: FMG)

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.

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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.

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