Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DURALASTIC ANATOMICAL MALAR IMPLANTS

K-Number: K971479 · 1997-07-18

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

Device Summary

DURALASTIC ANATOMICAL MALAR 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 K971479. The device is classified under product code LZK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURALASTIC ANATOMICAL MALAR IMPLANTS?

DURALASTIC ANATOMICAL MALAR 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 K971479.

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

DURALASTIC ANATOMICAL MALAR IMPLANTS received FDA 510(k) clearance on 1997-07-18, under 510(k) number K971479.

Who is the listed applicant for DURALASTIC ANATOMICAL MALAR 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 MALAR IMPLANTS?

The FDA product code for DURALASTIC ANATOMICAL MALAR IMPLANTS is LZK.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 IMPLANTSK971478DURALASTIC ANATOMICAL CHIN IMPLANTSK971480DURALASTIC I AND DURALASTIC IIK955368DURALASTIC IK955370DURALASTIC II

View all 9 devices →

Related Devices (Code: LZK)

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.

K021419AART MALAR IMPLANTAesthetic and Reconstructive Technologies, Inc.K002886IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)Implantech Associates, Inc.K992240PILLAR MALAR IMPLANTPillar Surgical, Inc.K983756SURGIFORM ANATOMICAL MALARSurgical Technology Laboratories, Inc.K982763SEARE BIOMEDICAL MALAR IMPLANTSSeare Biomedical Corp.K981835SILIMED MALAR IMPLANTSilimed, LLC

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.

↑