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FDA 510(k)

SSW-STERILE SOLUTION WARMER

K-Number: K002859 · 2000-11-16

ApplicantKmi Kolster Methods, Inc.
Decision Date2000-11-16
Product CodeLHC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SSW-STERILE SOLUTION WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Kmi Kolster Methods, Inc.. It received FDA 510(k) clearance on 2000-11-16 under 510(k) number K002859. 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 SSW-STERILE SOLUTION WARMER?

SSW-STERILE SOLUTION WARMER is a medical device that received FDA 510(k) clearance on 2000-11-16. The listed applicant is Kmi Kolster Methods, Inc.. The 510(k) number is K002859.

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

SSW-STERILE SOLUTION WARMER received FDA 510(k) clearance on 2000-11-16, under 510(k) number K002859.

Who is the listed applicant for SSW-STERILE SOLUTION WARMER?

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

What is the FDA product code for SSW-STERILE SOLUTION WARMER?

The FDA product code for SSW-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 Kmi Kolster Methods, 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.

K060414KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTUREK043591FEATHERLIFT EXTENDED APTOS THREADK012236STARS2000 POWER CANNULAK010702XUB EXTERNAL ULTRASOUNDK991203IRRIGATION OR INFUSION PUMP K PUMP

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

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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