FLEXIBLE ILLUMINATOR 10— 510(k) K840373

Name: FDA 510(k) clearance K840373
Creator: U.S. Food and Drug Administration
Published: 1984-04-24

Substantially Equivalent

Suncoast Medical Manufacturers, Inc.

FDA 510(k) clearance K840373 for FLEXIBLE ILLUMINATOR 10, Substantially Equivalent on 1984-04-24. Applicant: Suncoast Medical Manufacturers, Inc.. Device class: 2.

Clearance details

Applicant: Suncoast Medical Manufacturers, Inc.
Product code: Code FTF
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1984-01-27
Decision date: 1984-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTF

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K041621 — LITEPORT LP100 SURGICAL ILLUMINATOR2004-09-13
K840371 — FLEXIBLE ILLUMINATOR 51984-04-24
K840372 — FLEXIBLE ILLUMINATOR 151984-04-24

More clearances from Suncoast Medical Manufacturers, Inc.

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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.