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FDA 510(k)

PERSUNAL TAN, MODEL NO. HU-0208L

K-Number: K862263 · 1986-06-20

ApplicantSunthetic Engineering, Inc.
Decision Date1986-06-20
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERSUNAL TAN, MODEL NO. HU-0208L is the device name listed in this FDA 510(k) record. The listed applicant is Sunthetic Engineering, Inc.. It received FDA 510(k) clearance on 1986-06-20 under 510(k) number K862263. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERSUNAL TAN, MODEL NO. HU-0208L?

PERSUNAL TAN, MODEL NO. HU-0208L is a medical device that received FDA 510(k) clearance on 1986-06-20. The listed applicant is Sunthetic Engineering, Inc.. The 510(k) number is K862263.

When did PERSUNAL TAN, MODEL NO. HU-0208L receive FDA 510(k) clearance?

PERSUNAL TAN, MODEL NO. HU-0208L received FDA 510(k) clearance on 1986-06-20, under 510(k) number K862263.

Who is the listed applicant for PERSUNAL TAN, MODEL NO. HU-0208L?

The FDA 510(k) record lists Sunthetic Engineering, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERSUNAL TAN, MODEL NO. HU-0208L?

The FDA product code for PERSUNAL TAN, MODEL NO. HU-0208L is FTC.

Related Clinical Trials

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Other records listing Sunthetic Engineering, Inc. as applicant

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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Related Devices (Code: FTC)

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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