SWEEN UNIVERSAL BED RAIL PADS— 510(k) K810846

Name: FDA 510(k) clearance K810846
Creator: U.S. Food and Drug Administration
Published: 1981-04-17

Substantially Equivalent

Sween Corp.

FDA 510(k) clearance K810846 for SWEEN UNIVERSAL BED RAIL PADS, Substantially Equivalent on 1981-04-17. Applicant: Sween Corp.. Device class: 1.

Clearance details

Applicant: Sween Corp.
Product code: Code FNJ
Device class: Class 1
Regulation: 21 CFR 880.5120
Advisory panel: General Hospital
Date received: 1981-03-27
Decision date: 1981-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K884542 — SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED1988-11-21
K881725 — ENVIROTENT (BED)1988-11-08

More clearances from Sween Corp.

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K926389 — SWEEN WOUND CARE-COLLAGEN WOUND DRESSING1993-07-08
K912506 — CRITIC-AID WOUND DRESSING1992-03-02
K840723 — SWEEN-A-PEEL PERISTOMAL WAFERS1984-05-07

Adverse events under product code FNJ

product code FNJ

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.