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FDA 510(k)

GDC 588 CASTING ALLOY

K-Number: K901533 · 1990-05-02

ApplicantThe J.M. Co.
Decision Date1990-05-02
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GDC 588 CASTING ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is The J.M. Co.. It received FDA 510(k) clearance on 1990-05-02 under 510(k) number K901533. 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 GDC 588 CASTING ALLOY?

GDC 588 CASTING ALLOY is a medical device that received FDA 510(k) clearance on 1990-05-02. The listed applicant is The J.M. Co.. The 510(k) number is K901533.

When did GDC 588 CASTING ALLOY receive FDA 510(k) clearance?

GDC 588 CASTING ALLOY received FDA 510(k) clearance on 1990-05-02, under 510(k) number K901533.

Who is the listed applicant for GDC 588 CASTING ALLOY?

The FDA 510(k) record lists The J.M. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GDC 588 CASTING ALLOY?

The FDA product code for GDC 588 CASTING ALLOY is EJT.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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