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FDA 510(k)

DURALASTIC ANATOMICAL CHIN IMPLANTS

K-Number: K971478 · 1997-07-18

ApplicantAllied Biomedical Corp.
Decision Date1997-07-18
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DURALASTIC ANATOMICAL CHIN IMPLANTS 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 1997-07-18 under 510(k) number K971478. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURALASTIC ANATOMICAL CHIN IMPLANTS?

DURALASTIC ANATOMICAL CHIN IMPLANTS is a medical device that received FDA 510(k) clearance on 1997-07-18. The listed applicant is Allied Biomedical Corp.. The 510(k) number is K971478.

When did DURALASTIC ANATOMICAL CHIN IMPLANTS receive FDA 510(k) clearance?

DURALASTIC ANATOMICAL CHIN IMPLANTS received FDA 510(k) clearance on 1997-07-18, under 510(k) number K971478.

Who is the listed applicant for DURALASTIC ANATOMICAL CHIN IMPLANTS?

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 ANATOMICAL CHIN IMPLANTS?

The FDA product code for DURALASTIC ANATOMICAL CHIN IMPLANTS is FWP.

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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 SHEETINGK971479DURALASTIC ANATOMICAL MALAR IMPLANTSK971481DURALASTIC ANATOMICAL NASAL IMPLANTSK971480DURALASTIC I AND DURALASTIC IIK955368DURALASTIC IK955370DURALASTIC II

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Related Devices (Code: FWP)

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.

K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KGK232593FITme Customized Silicone ImplantKeosan Trading Co.K200610Customized Contour ImplantImplantech Associates, Inc.K191130Customized Contour ImplantImplantech Associates, Inc.K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KGK153508Stryker CMF MEDPOR Customized ImplantStryker

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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