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FDA 510(k)

SUN-LITE WHITE SPOT

K-Number: K841588 · 1984-05-22

ApplicantSuncoast Medical Manufacturers, Inc.
Decision Date1984-05-22
Product CodeKYT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SUN-LITE WHITE SPOT is the device name listed in this FDA 510(k) record. The listed applicant is Suncoast Medical Manufacturers, Inc.. It received FDA 510(k) clearance on 1984-05-22 under 510(k) number K841588. The device is classified under product code KYT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUN-LITE WHITE SPOT?

SUN-LITE WHITE SPOT is a medical device that received FDA 510(k) clearance on 1984-05-22. The listed applicant is Suncoast Medical Manufacturers, Inc.. The 510(k) number is K841588.

When did SUN-LITE WHITE SPOT receive FDA 510(k) clearance?

SUN-LITE WHITE SPOT received FDA 510(k) clearance on 1984-05-22, under 510(k) number K841588.

Who is the listed applicant for SUN-LITE WHITE SPOT?

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

What is the FDA product code for SUN-LITE WHITE SPOT?

The FDA product code for SUN-LITE WHITE SPOT is KYT.

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Other records listing Suncoast Medical Manufacturers, 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.

K841604ADJUST-A-TEMP HIGH TEMPERATUREK841603ADJUST-A-TEMP MICROK841459REPLACE-A-TIP ADJUST. LOW TEMP.-K841509REPLACE-A-TIP ADJUSTABLE HIGH TEMP.K841591PYRO-TIPK840376SURG-A STAT LOOP TIP

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Related Devices (Code: KYT)

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.

K920782OLYMPIC TRANS-LITEOlympic Medical Corp.K841589C-LITESuncoast Medical Manufacturers, Inc.K791001PENLIGHT/SWAB HOLDERConcept, Inc.K781228PENLIGHTSAbco Dealers, Inc.K760972TYCOS DIAGNOSTIC PENLIGHTTaylor Instrument Analytics Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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