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FDA 510(k)

GOLD CORE 55

K-Number: K993173 · 1999-10-26

ApplicantJeneric/Pentron, Inc.
Decision Date1999-10-26
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GOLD CORE 55 is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 1999-10-26 under 510(k) number K993173. 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 GOLD CORE 55?

GOLD CORE 55 is a medical device that received FDA 510(k) clearance on 1999-10-26. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K993173.

When did GOLD CORE 55 receive FDA 510(k) clearance?

GOLD CORE 55 received FDA 510(k) clearance on 1999-10-26, under 510(k) number K993173.

Who is the listed applicant for GOLD CORE 55?

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

What is the FDA product code for GOLD CORE 55?

The FDA product code for GOLD CORE 55 is EJT.

Other records listing Jeneric/Pentron, Inc. as applicant

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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.

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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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