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FDA 510(k)

SUNMAKER (SUN TANNING BED)

K-Number: K803090 · 1981-01-22

Decision Date1981-01-22
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUNMAKER (SUN TANNING BED) is the device name listed in this FDA 510(k) record. The listed applicant is Sunmaker, Inc.. It received FDA 510(k) clearance on 1981-01-22 under 510(k) number K803090. 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 SUNMAKER (SUN TANNING BED)?

SUNMAKER (SUN TANNING BED) is a medical device that received FDA 510(k) clearance on 1981-01-22. The listed applicant is Sunmaker, Inc.. The 510(k) number is K803090.

When did SUNMAKER (SUN TANNING BED) receive FDA 510(k) clearance?

SUNMAKER (SUN TANNING BED) received FDA 510(k) clearance on 1981-01-22, under 510(k) number K803090.

Who is the listed applicant for SUNMAKER (SUN TANNING BED)?

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

What is the FDA product code for SUNMAKER (SUN TANNING BED)?

The FDA product code for SUNMAKER (SUN TANNING BED) is LEJ.

Related Clinical Trials

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.

Other records listing Sunmaker, 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.

Related Devices (Code: LEJ)

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.

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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