FDA 510(k)

GPW-SF

K-Number: K011659 · 2001-08-27

Decision Date2001-08-27

Product CodeEJT

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GPW-SF 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 K011659. 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 GPW-SF?

GPW-SF 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 K011659.

When did GPW-SF receive FDA 510(k) clearance?

GPW-SF received FDA 510(k) clearance on 2001-08-27, under 510(k) number K011659.

Who is the listed applicant for GPW-SF?

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 GPW-SF?

The FDA product code for GPW-SF 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.

K011661CONCORD 88 K011626CONCORD 72 K011628CONCORD 82 K964941EL DORADO 40 K964940TAOS 28 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.