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FDA 510(k)

HAWN UNIVERSAL

K-Number: K953158 · 1995-10-05

ApplicantMetal-Tech
Decision Date1995-10-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HAWN UNIVERSAL is the device name listed in this FDA 510(k) record. The listed applicant is Metal-Tech. It received FDA 510(k) clearance on 1995-10-05 under 510(k) number K953158. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAWN UNIVERSAL?

HAWN UNIVERSAL is a medical device that received FDA 510(k) clearance on 1995-10-05. The listed applicant is Metal-Tech. The 510(k) number is K953158.

When did HAWN UNIVERSAL receive FDA 510(k) clearance?

HAWN UNIVERSAL received FDA 510(k) clearance on 1995-10-05, under 510(k) number K953158.

Who is the listed applicant for HAWN UNIVERSAL?

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

What is the FDA product code for HAWN UNIVERSAL?

The FDA product code for HAWN UNIVERSAL is DZE.

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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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