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FDA 510(k)

HANDPIECE SYSTEM I/A

K-Number: K830413 · 1983-04-05

ApplicantUxtra Corp.
Decision Date1983-04-05
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HANDPIECE SYSTEM I/A is the device name listed in this FDA 510(k) record. The listed applicant is Uxtra Corp.. It received FDA 510(k) clearance on 1983-04-05 under 510(k) number K830413. The device is classified under product code HQZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDPIECE SYSTEM I/A?

HANDPIECE SYSTEM I/A is a medical device that received FDA 510(k) clearance on 1983-04-05. The listed applicant is Uxtra Corp.. The 510(k) number is K830413.

When did HANDPIECE SYSTEM I/A receive FDA 510(k) clearance?

HANDPIECE SYSTEM I/A received FDA 510(k) clearance on 1983-04-05, under 510(k) number K830413.

Who is the listed applicant for HANDPIECE SYSTEM I/A?

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

What is the FDA product code for HANDPIECE SYSTEM I/A?

The FDA product code for HANDPIECE SYSTEM I/A is HQZ.

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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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