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 I AND DURALASTIC II

K-Number: K971480 · 1997-05-28

ApplicantAllied Biomedical Corp.
Decision Date1997-05-28
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DURALASTIC I AND 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 1997-05-28 under 510(k) number K971480. 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 I AND DURALASTIC II?

DURALASTIC I AND DURALASTIC II is a medical device that received FDA 510(k) clearance on 1997-05-28. The listed applicant is Allied Biomedical Corp.. The 510(k) number is K971480.

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

DURALASTIC I AND DURALASTIC II received FDA 510(k) clearance on 1997-05-28, under 510(k) number K971480.

Who is the listed applicant for DURALASTIC I AND 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 I AND DURALASTIC II?

The FDA product code for DURALASTIC I AND DURALASTIC II is MIB.

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 SHEETINGK971479DURALASTIC ANATOMICAL MALAR IMPLANTSK971481DURALASTIC ANATOMICAL NASAL IMPLANTSK971478DURALASTIC ANATOMICAL CHIN IMPLANTSK955368DURALASTIC IK955370DURALASTIC II

View all 9 devices →

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.

↑