FDA 510(k)

TAOS 28

K-Number: K964940 · 1997-01-13

Decision Date1997-01-13

Product CodeEJT

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

TAOS 28 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 1997-01-13 under 510(k) number K964940. 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 TAOS 28?

TAOS 28 is a medical device that received FDA 510(k) clearance on 1997-01-13. The listed applicant is Gateway Alloys, Inc.. The 510(k) number is K964940.

When did TAOS 28 receive FDA 510(k) clearance?

TAOS 28 received FDA 510(k) clearance on 1997-01-13, under 510(k) number K964940.

Who is the listed applicant for TAOS 28?

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 TAOS 28?

The FDA product code for TAOS 28 is EJT.

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-SF K011661CONCORD 88 K011628CONCORD 82 K011626CONCORD 72 K964941EL DORADO 40 K964950LA PLATA 28 (PM-28)

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Related Devices (Code: EJT)

K052463PROMETAL HN86Prometal Technologies K041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KG K040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KG K040043NDX-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.