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FDA 510(k)

LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM

K-Number: K021012 · 2002-06-25

ApplicantQuality Medical Solusions, LLC
Decision Date2002-06-25
Product CodeHDY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM is the device name listed in this FDA 510(k) record. The listed applicant is Quality Medical Solusions, LLC. It received FDA 510(k) clearance on 2002-06-25 under 510(k) number K021012. The device is classified under product code HDY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM?

LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM is a medical device that received FDA 510(k) clearance on 2002-06-25. The listed applicant is Quality Medical Solusions, LLC. The 510(k) number is K021012.

When did LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM receive FDA 510(k) clearance?

LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM received FDA 510(k) clearance on 2002-06-25, under 510(k) number K021012.

Who is the listed applicant for LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM?

The FDA 510(k) record lists Quality Medical Solusions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM?

The FDA product code for LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM is HDY.

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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Related Devices (Code: HDY)

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.

K040625ATAD ARD CATHETERAtad Developments , Ltd.K011512MMODIFICATION TO LAMINARIAA & A Medical, Inc.K955072LAMINARIACti Corp., Ltd.K892220LAMINARIA TENTBerkeley MedevicesK881295LAMINARIA CUREXHarold W. Berger Co.K881312LAMINARIABusse Hospital Disposables, 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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