SOFSWAB— 510(k) K871879

Name: FDA 510(k) clearance K871879
Creator: U.S. Food and Drug Administration
Published: 1987-07-28

Substantially Equivalent

Plastic Engineered Products Co.

FDA 510(k) clearance K871879 for SOFSWAB, Substantially Equivalent on 1987-07-28. Applicant: Plastic Engineered Products Co.. Device class: 1.

Clearance details

Applicant: Plastic Engineered Products Co.
Product code: Code EFW
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 1987-05-14
Decision date: 1987-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

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.