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FDA 510(k)

GK ALLOY

K-Number: K891390 · 1989-04-17

ApplicantChina Link, Inc.
Decision Date1989-04-17
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GK ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is China Link, Inc.. It received FDA 510(k) clearance on 1989-04-17 under 510(k) number K891390. The device is classified under product code EJJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GK ALLOY?

GK ALLOY is a medical device that received FDA 510(k) clearance on 1989-04-17. The listed applicant is China Link, Inc.. The 510(k) number is K891390.

When did GK ALLOY receive FDA 510(k) clearance?

GK ALLOY received FDA 510(k) clearance on 1989-04-17, under 510(k) number K891390.

Who is the listed applicant for GK ALLOY?

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

What is the FDA product code for GK ALLOY?

The FDA product code for GK ALLOY is EJJ.

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Related Devices (Code: EJJ)

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.

K053114SILVERFILDunia Perwira Manufacturing Sdn. Bhd.K051010SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70SeptodontK033434BESTALOYWe Dong Myung Dental Industrial Co., Ltd.K032152BENCO ADMIXSouthern Dental Industries, Inc.K031658BENCO SPHERICALSouthern Dental Industries, Inc.K020452HIGH SILVER CONVENTIONALAb Ardent

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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