FDA 510(k)

HI-TIP HIGH TEMPERATURE REPLACEMENT TIP

K-Number: K945758 · 1995-04-21

Decision Date1995-04-21

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HI-TIP HIGH TEMPERATURE REPLACEMENT TIP is the device name listed in this FDA 510(k) record. The listed applicant is Aaron Medical Industries. It received FDA 510(k) clearance on 1995-04-21 under 510(k) number K945758. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI-TIP HIGH TEMPERATURE REPLACEMENT TIP?

HI-TIP HIGH TEMPERATURE REPLACEMENT TIP is a medical device that received FDA 510(k) clearance on 1995-04-21. The listed applicant is Aaron Medical Industries. The 510(k) number is K945758.

When did HI-TIP HIGH TEMPERATURE REPLACEMENT TIP receive FDA 510(k) clearance?

HI-TIP HIGH TEMPERATURE REPLACEMENT TIP received FDA 510(k) clearance on 1995-04-21, under 510(k) number K945758.

Who is the listed applicant for HI-TIP HIGH TEMPERATURE REPLACEMENT TIP?

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

What is the FDA product code for HI-TIP HIGH TEMPERATURE REPLACEMENT TIP?

The FDA product code for HI-TIP HIGH TEMPERATURE REPLACEMENT TIP is GEI.

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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.