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FDA 510(k)

SUN-LITE 1

K-Number: K840456 · 1984-04-13

ApplicantSuncoast Medical Manufacturers, Inc.
Decision Date1984-04-13
Product Code
DecisionSubstantially Equivalent

Device Summary

SUN-LITE 1 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 1984-04-13 under 510(k) number K840456. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUN-LITE 1?

SUN-LITE 1 is a medical device that received FDA 510(k) clearance on 1984-04-13. The listed applicant is Suncoast Medical Manufacturers, Inc.. The 510(k) number is K840456.

When did SUN-LITE 1 receive FDA 510(k) clearance?

SUN-LITE 1 received FDA 510(k) clearance on 1984-04-13, under 510(k) number K840456.

Who is the listed applicant for SUN-LITE 1?

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

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 TEMPERATUREK841509REPLACE-A-TIP ADJUSTABLE HIGH TEMP.K841603ADJUST-A-TEMP MICROK841459REPLACE-A-TIP ADJUST. LOW TEMP.-K841591PYRO-TIPK840376SURG-A STAT LOOP TIP

View all 31 devices →

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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