510(k) Report

FDA applicant

Sellstrom Mfg. Co.

Palatine, IL2 decisions1993–19940 recalls

FDA records 2 decisions for Sellstrom Mfg. Co. (Palatine, IL) from 1993 to 1994: 2 510(k) clearances. All are in product code HOY (Shield, Eye, Ophthalmic (Including Sunlamp…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Sellstrom Mfg. Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sellstrom Mfg. Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sellstrom Mfg. Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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