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FDA 510(k)

SOLDER 615

K-Number: K964708 · 1996-12-16

ApplicantGateway Alloys, Inc.
Decision Date1996-12-16
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLDER 615 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 1996-12-16 under 510(k) number K964708. 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 SOLDER 615?

SOLDER 615 is a medical device that received FDA 510(k) clearance on 1996-12-16. The listed applicant is Gateway Alloys, Inc.. The 510(k) number is K964708.

When did SOLDER 615 receive FDA 510(k) clearance?

SOLDER 615 received FDA 510(k) clearance on 1996-12-16, under 510(k) number K964708.

Who is the listed applicant for SOLDER 615?

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 SOLDER 615?

The FDA product code for SOLDER 615 is EJT.

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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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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 72K964940TAOS 28K964941EL DORADO 40

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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