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FDA 510(k)

ACUTE HEMODIALYSIS TRAYS

K-Number: K833139 · 1983-12-22

ApplicantIntermed, Inc.
Decision Date1983-12-22
Product CodeKNZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACUTE HEMODIALYSIS TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Intermed, Inc.. It received FDA 510(k) clearance on 1983-12-22 under 510(k) number K833139. 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 ACUTE HEMODIALYSIS TRAYS?

ACUTE HEMODIALYSIS TRAYS is a medical device that received FDA 510(k) clearance on 1983-12-22. The listed applicant is Intermed, Inc.. The 510(k) number is K833139.

When did ACUTE HEMODIALYSIS TRAYS receive FDA 510(k) clearance?

ACUTE HEMODIALYSIS TRAYS received FDA 510(k) clearance on 1983-12-22, under 510(k) number K833139.

Who is the listed applicant for ACUTE HEMODIALYSIS TRAYS?

The FDA 510(k) record lists Intermed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUTE HEMODIALYSIS TRAYS?

The FDA product code for ACUTE HEMODIALYSIS TRAYS is KNZ.

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Other records listing Intermed, Inc. 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.

K900857NON STERILE PARENTERAL SUPPLY KITK842166INTERMED, INS STERILE WATER/SALINEK833126DRESSING CHANGE TRAYSK833574PERCUTANEOUS SHEATH INTRODUCER TRAYSK833573CENTRAL VEIN CATH. TRAY CC-20-1420K833059SUCTION CATHETER TRAYS

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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.K841119TOPS DISPOS. INFUSION SET/HEMODIALYSISTop Surgical Manufacturers Co.

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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