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)

AMALCODEN

K-Number: K915666 · 1992-03-25

ApplicantMion International Corp.
Decision Date1992-03-25
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMALCODEN is the device name listed in this FDA 510(k) record. The listed applicant is Mion International Corp.. It received FDA 510(k) clearance on 1992-03-25 under 510(k) number K915666. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMALCODEN?

AMALCODEN is a medical device that received FDA 510(k) clearance on 1992-03-25. The listed applicant is Mion International Corp.. The 510(k) number is K915666.

When did AMALCODEN receive FDA 510(k) clearance?

AMALCODEN received FDA 510(k) clearance on 1992-03-25, under 510(k) number K915666.

Who is the listed applicant for AMALCODEN?

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

What is the FDA product code for AMALCODEN?

The FDA product code for AMALCODEN is EMA.

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 Mion International 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.

K942808TYPE I GLASS IONOMER CEMENTK926376MION 525

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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.

↑