BA-CPAS— 510(k) K945154

Name: FDA 510(k) clearance K945154
Creator: U.S. Food and Drug Administration
Published: 1995-01-13

Substantially Equivalent

Nobelpharma USA, Inc.

FDA 510(k) clearance K945154 for BA-CPAS, Substantially Equivalent on 1995-01-13. Applicant: Nobelpharma USA, Inc.. Device class: 2.

Clearance details

Applicant: Nobelpharma USA, Inc.
Product code: Code FZE
Device class: Class 2
Regulation: 21 CFR 878.3680
Advisory panel: General, Plastic Surgery
Date received: 1994-10-21
Decision date: 1995-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

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.