SUN-LITE WHITE SPOT— 510(k) K841588

Name: FDA 510(k) clearance K841588
Creator: U.S. Food and Drug Administration
Published: 1984-05-22

Substantially Equivalent

Suncoast Medical Manufacturers, Inc.

FDA 510(k) clearance K841588 for SUN-LITE WHITE SPOT, Substantially Equivalent on 1984-05-22. Applicant: Suncoast Medical Manufacturers, Inc.. Device class: 1.

Clearance details

Applicant: Suncoast Medical Manufacturers, Inc.
Product code: Code KYT
Device class: Class 1
Regulation: 21 CFR 880.6350
Advisory panel: General Hospital
Date received: 1984-04-18
Decision date: 1984-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K760972 — TYCOS DIAGNOSTIC PENLIGHT1977-01-26

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K841459 — REPLACE-A-TIP ADJUST. LOW TEMP.-1984-12-07
K841509 — REPLACE-A-TIP ADJUSTABLE HIGH TEMP.1984-12-07
K841603 — ADJUST-A-TEMP MICRO1984-12-07
K841604 — ADJUST-A-TEMP HIGH TEMPERATURE1984-12-07
K841591 — PYRO-TIP1984-10-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.