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FDA 510(k)

UNISUN

K-Number: K955539 · 1996-01-03

ApplicantSteven Chen
Decision Date1996-01-03
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UNISUN is the device name listed in this FDA 510(k) record. The listed applicant is Steven Chen. It received FDA 510(k) clearance on 1996-01-03 under 510(k) number K955539. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNISUN?

UNISUN is a medical device that received FDA 510(k) clearance on 1996-01-03. The listed applicant is Steven Chen. The 510(k) number is K955539.

When did UNISUN receive FDA 510(k) clearance?

UNISUN received FDA 510(k) clearance on 1996-01-03, under 510(k) number K955539.

Who is the listed applicant for UNISUN?

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

What is the FDA product code for UNISUN?

The FDA product code for UNISUN is HQY.

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Related Devices (Code: HQY)

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

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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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