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FDA 510(k)

AURIUM G14

K-Number: K940930 · 1994-04-04

ApplicantArgen Precious Metals, Inc.
Decision Date1994-04-04
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AURIUM G14 is the device name listed in this FDA 510(k) record. The listed applicant is Argen Precious Metals, Inc.. It received FDA 510(k) clearance on 1994-04-04 under 510(k) number K940930. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURIUM G14?

AURIUM G14 is a medical device that received FDA 510(k) clearance on 1994-04-04. The listed applicant is Argen Precious Metals, Inc.. The 510(k) number is K940930.

When did AURIUM G14 receive FDA 510(k) clearance?

AURIUM G14 received FDA 510(k) clearance on 1994-04-04, under 510(k) number K940930.

Who is the listed applicant for AURIUM G14?

The FDA 510(k) record lists Argen Precious Metals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AURIUM G14?

The FDA product code for AURIUM G14 is EJT.

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Other records listing Argen Precious Metals, Inc. 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.

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Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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