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FDA 510(k)

PROMETAL HN86

K-Number: K052463 · 2005-10-14

ApplicantPrometal Technologies
Decision Date2005-10-14
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROMETAL HN86 is the device name listed in this FDA 510(k) record. The listed applicant is Prometal Technologies. It received FDA 510(k) clearance on 2005-10-14 under 510(k) number K052463. 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 PROMETAL HN86?

PROMETAL HN86 is a medical device that received FDA 510(k) clearance on 2005-10-14. The listed applicant is Prometal Technologies. The 510(k) number is K052463.

When did PROMETAL HN86 receive FDA 510(k) clearance?

PROMETAL HN86 received FDA 510(k) clearance on 2005-10-14, under 510(k) number K052463.

Who is the listed applicant for PROMETAL HN86?

The FDA 510(k) record lists Prometal Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROMETAL HN86?

The FDA product code for PROMETAL HN86 is EJT.

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Related Devices (Code: EJT)

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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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