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FDA 510(k)

STERILE SOLUTION WARMER

K-Number: K833944 · 1984-01-25

ApplicantNational Fabtronix, Inc.
Decision Date1984-01-25
Product CodeLHC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STERILE SOLUTION WARMER is the device name listed in this FDA 510(k) record. The listed applicant is National Fabtronix, Inc.. It received FDA 510(k) clearance on 1984-01-25 under 510(k) number K833944. The device is classified under product code LHC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE SOLUTION WARMER?

STERILE SOLUTION WARMER is a medical device that received FDA 510(k) clearance on 1984-01-25. The listed applicant is National Fabtronix, Inc.. The 510(k) number is K833944.

When did STERILE SOLUTION WARMER receive FDA 510(k) clearance?

STERILE SOLUTION WARMER received FDA 510(k) clearance on 1984-01-25, under 510(k) number K833944.

Who is the listed applicant for STERILE SOLUTION WARMER?

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

What is the FDA product code for STERILE SOLUTION WARMER?

The FDA product code for STERILE SOLUTION WARMER is LHC.

Related Clinical Trials

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 National Fabtronix, 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.

K832343DERMALAND DURAL HOOKS

Related Devices (Code: LHC)

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.

K153713Getinge Series Warming CabinetGetinge Sourcing, LLCK152522ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc.K083417INTRATEMP SOLUTION WARMERC Change Surgical, LLCK080609SWC/DWC WARMING CABINETSMac MedicalK051819C CHANGE SOLUTION WARMERC Change Surgical, LLCK023282ORS-3000LDO.R. Solutions, Inc.

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.

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