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FDA 510(k)

DURALASTIC II

K-Number: K955370 · 1996-02-08

ApplicantAllied Biomedical Corp.
Decision Date1996-02-08
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DURALASTIC II is the device name listed in this FDA 510(k) record. The listed applicant is Allied Biomedical Corp.. It received FDA 510(k) clearance on 1996-02-08 under 510(k) number K955370. The device is classified under product code MIB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURALASTIC II?

DURALASTIC II is a medical device that received FDA 510(k) clearance on 1996-02-08. The listed applicant is Allied Biomedical Corp.. The 510(k) number is K955370.

When did DURALASTIC II receive FDA 510(k) clearance?

DURALASTIC II received FDA 510(k) clearance on 1996-02-08, under 510(k) number K955370.

Who is the listed applicant for DURALASTIC II?

The FDA 510(k) record lists Allied Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURALASTIC II?

The FDA product code for DURALASTIC II is MIB.

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Other records listing Allied Biomedical Corp. 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.

K982051KELOCATE SHEETINGK971481DURALASTIC ANATOMICAL NASAL IMPLANTSK971479DURALASTIC ANATOMICAL MALAR IMPLANTSK971478DURALASTIC ANATOMICAL CHIN IMPLANTSK971480DURALASTIC I AND DURALASTIC IIK955368DURALASTIC I

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Related Devices (Code: MIB)

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.

K241150MISTI Silicone ImplantKeosan Trading Co.K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc.K222748ShiNeo Silicone ImplantShineo Technology Co., Ltd.K200073AugMENTA Penile ImplantAugmenta, LLCK220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.K193392BioSiCar Silicone ImplantMetalware Technology Corp.

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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