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FDA 510(k)

CONCORD 88

K-Number: K011661 · 2001-08-27

ApplicantGateway Alloys, Inc.
Decision Date2001-08-27
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CONCORD 88 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 2001-08-27 under 510(k) number K011661. 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 CONCORD 88?

CONCORD 88 is a medical device that received FDA 510(k) clearance on 2001-08-27. The listed applicant is Gateway Alloys, Inc.. The 510(k) number is K011661.

When did CONCORD 88 receive FDA 510(k) clearance?

CONCORD 88 received FDA 510(k) clearance on 2001-08-27, under 510(k) number K011661.

Who is the listed applicant for CONCORD 88?

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 CONCORD 88?

The FDA product code for CONCORD 88 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-SFK011626CONCORD 72K011628CONCORD 82K964941EL DORADO 40K964940TAOS 28K964950LA PLATA 28 (PM-28)

View all 31 devices →

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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