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FDA 510(k)

SUNSATION

K-Number: K801429 · 1980-07-28

ApplicantFashion, Inc.
Decision Date1980-07-28
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUNSATION is the device name listed in this FDA 510(k) record. The listed applicant is Fashion, Inc.. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801429. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNSATION?

SUNSATION is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Fashion, Inc.. The 510(k) number is K801429.

When did SUNSATION receive FDA 510(k) clearance?

SUNSATION received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801429.

Who is the listed applicant for SUNSATION?

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

What is the FDA product code for SUNSATION?

The FDA product code for SUNSATION is LEJ.

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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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