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FDA 510(k)

TOPS DISPOS. INFUSION SET/HEMODIALYSIS

K-Number: K841119 · 1984-04-20

ApplicantTop Surgical Manufacturers Co.
Decision Date1984-04-20
Product CodeKNZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TOPS DISPOS. INFUSION SET/HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Top Surgical Manufacturers Co.. It received FDA 510(k) clearance on 1984-04-20 under 510(k) number K841119. The device is classified under product code KNZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOPS DISPOS. INFUSION SET/HEMODIALYSIS?

TOPS DISPOS. INFUSION SET/HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 1984-04-20. The listed applicant is Top Surgical Manufacturers Co.. The 510(k) number is K841119.

When did TOPS DISPOS. INFUSION SET/HEMODIALYSIS receive FDA 510(k) clearance?

TOPS DISPOS. INFUSION SET/HEMODIALYSIS received FDA 510(k) clearance on 1984-04-20, under 510(k) number K841119.

Who is the listed applicant for TOPS DISPOS. INFUSION SET/HEMODIALYSIS?

The FDA 510(k) record lists Top Surgical Manufacturers Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOPS DISPOS. INFUSION SET/HEMODIALYSIS?

The FDA product code for TOPS DISPOS. INFUSION SET/HEMODIALYSIS is KNZ.

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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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Other records listing Top Surgical Manufacturers Co. 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.

K844343TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPEK843415TOP HYPODERMIC SYRINGE LUER LOCKK843313TOP DISPOSABLE SPINAL NEEDLEK843414TOP HYPODERMIC SYRINGE PISTONK841025TOP DISPOSABLE INFUSION SETK832624TOP VENULA I.V. CATHETER SET

View all 12 devices →

Related Devices (Code: KNZ)

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.

K842039ARGON DUAL LUMEN HEMODIALYSIS, CATHETERArgon Medical Corp.K844612ACUTE HEMODIALYSIS TRAYSPackaging Technologies, Inc.K842864VACCESS FEMORAL CANNULAVas-Cath of Canada , Ltd.K842416DUO FLOW CATHETER-MC 54Medical Components, Inc.K841530DOUBLE LUMEN SUBLCAVIAN-FEMORALMedical Components, Inc.K840424HEMOCATH REPAIR KITQuinton, Inc.

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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