K840427Substantially Equivalent

Sun-Lite Blue Spot

Name: K840427 Sun-Lite Blue Spot
Creator: Suncoast Medical Manufacturers, Inc.
Published: 1984-05-09
License: https://open.fda.gov/license/

Suncoast Medical Manufacturers, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K840427 is the FDA 510(k) clearance record for SUN-LITE BLUE SPOT, cleared for Suncoast Medical Manufacturers, Inc. on 1984-05-09. FDA records list 31 510(k) clearances for Suncoast Medical Manufacturers, Inc., from 1984-01-27 to 1984-12-07. As of 2026-09-10, FDA records show no recalls naming K840427.

Clearance record

Decision date: 1984-05-09
Received: 1984-01-31 (99 days to decision)
Review panel: Unknown
Applicant: Suncoast Medical Manufacturers, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No