K833679Substantially Equivalent

Laser Protective Eyeshield

Name: K833679 Laser Protective Eyeshield
Creator: Stefanovsky & Assoc.
Published: 1985-02-27
License: https://open.fda.gov/license/

Stefanovsky & Assoc., Walker MI / Traditional, Substantially Equivalent

FDA source

K833679 is the FDA 510(k) clearance record for LASER PROTECTIVE EYESHIELD, cleared for Stefanovsky & Assoc. on 1985-02-27. FDA records list 3 510(k) clearances for Stefanovsky & Assoc., from 1983-12-30 to 1997-03-18. As of 2026-09-10, FDA records show no recalls naming K833679.

Clearance record

Decision date: 1985-02-27
Received: 1983-09-06 (540 days to decision)
Review panel: Unknown
Applicant: Stefanovsky & Assoc. 4221 Richmond Rd., NW, Walker MI
Third party review: No