C-LITE— 510(k) K841589

Substantially Equivalent

Suncoast Medical Manufacturers, Inc.

FDA 510(k) clearance K841589 for C-LITE, 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: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYT

K920782 — OLYMPIC TRANS-LITE1992-03-27
K841588 — SUN-LITE WHITE SPOT1984-05-22
K791001 — PENLIGHT/SWAB HOLDER1979-06-22
K781228 — PENLIGHTS1978-09-07
K760972 — TYCOS DIAGNOSTIC PENLIGHT1977-01-26

More clearances from Suncoast Medical Manufacturers, Inc.

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.