ROLL-A-SET— 510(k) K810918

Name: FDA 510(k) clearance K810918
Creator: U.S. Food and Drug Administration
Published: 1981-05-21

Substantially Equivalent

Principle Business Ent.

FDA 510(k) clearance K810918 for ROLL-A-SET, Substantially Equivalent on 1981-05-21. Applicant: Principle Business Ent.. Device class: 2.

Clearance details

Applicant: Principle Business Ent.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1981-04-06
Decision date: 1981-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.