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FDA 510(k)

SUNBRONZE SB24C/65 ULTRA

K-Number: K896983 · 1990-01-03

ApplicantSunbronze
Decision Date1990-01-03
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUNBRONZE SB24C/65 ULTRA is the device name listed in this FDA 510(k) record. The listed applicant is Sunbronze. It received FDA 510(k) clearance on 1990-01-03 under 510(k) number K896983. 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 SUNBRONZE SB24C/65 ULTRA?

SUNBRONZE SB24C/65 ULTRA is a medical device that received FDA 510(k) clearance on 1990-01-03. The listed applicant is Sunbronze. The 510(k) number is K896983.

When did SUNBRONZE SB24C/65 ULTRA receive FDA 510(k) clearance?

SUNBRONZE SB24C/65 ULTRA received FDA 510(k) clearance on 1990-01-03, under 510(k) number K896983.

Who is the listed applicant for SUNBRONZE SB24C/65 ULTRA?

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

What is the FDA product code for SUNBRONZE SB24C/65 ULTRA?

The FDA product code for SUNBRONZE SB24C/65 ULTRA 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.

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Other records listing Sunbronze 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.

K896191SUNTANNING BED, INC. T12 UVA TANNING LAMPSK895325SUNTANNING BED

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.

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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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