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FDA 510(k)

MITRATHANE DRESSING

K-Number: K850535 · 1985-06-05

ApplicantMitral Medical , Ltd.
Decision Date1985-06-05
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

MITRATHANE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Mitral Medical , Ltd.. It received FDA 510(k) clearance on 1985-06-05 under 510(k) number K850535. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MITRATHANE DRESSING?

MITRATHANE DRESSING is a medical device that received FDA 510(k) clearance on 1985-06-05. The listed applicant is Mitral Medical , Ltd.. The 510(k) number is K850535.

When did MITRATHANE DRESSING receive FDA 510(k) clearance?

MITRATHANE DRESSING received FDA 510(k) clearance on 1985-06-05, under 510(k) number K850535.

Who is the listed applicant for MITRATHANE DRESSING?

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

What is the FDA product code for MITRATHANE DRESSING?

The FDA product code for MITRATHANE DRESSING is NAD.

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Related Devices (Code: NAD)

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.

K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.K102403SAM CHEST SEAL WITH VAVLE; SAM CHEST SEALSam Medical ProductsK091133APLION TOPICAL CARE SYSTEMAplion Medical,LlcK072560ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)Teikoku Pharma USA, Inc.K080524CENTURION SORBAVIEW OTCTri-State Hospital Supply Corp.K060046DERMASTREAMEnzysurge , Ltd.

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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