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FDA 510(k)

PALLADIA 85 (PM-13)

K-Number: K964838 · 1996-12-20

ApplicantGateway Alloys, Inc.
Decision Date1996-12-20
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PALLADIA 85 (PM-13) is the device name listed in this FDA 510(k) record. The listed applicant is Gateway Alloys, Inc.. It received FDA 510(k) clearance on 1996-12-20 under 510(k) number K964838. 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 PALLADIA 85 (PM-13)?

PALLADIA 85 (PM-13) is a medical device that received FDA 510(k) clearance on 1996-12-20. The listed applicant is Gateway Alloys, Inc.. The 510(k) number is K964838.

When did PALLADIA 85 (PM-13) receive FDA 510(k) clearance?

PALLADIA 85 (PM-13) received FDA 510(k) clearance on 1996-12-20, under 510(k) number K964838.

Who is the listed applicant for PALLADIA 85 (PM-13)?

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

What is the FDA product code for PALLADIA 85 (PM-13)?

The FDA product code for PALLADIA 85 (PM-13) is EJT.

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Other records listing Gateway Alloys, 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.

K011659GPW-SFK011661CONCORD 88K011628CONCORD 82K011626CONCORD 72K964949AURORA 53K964941EL DORADO 40

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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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