TASSAWAY— 510(k) K803250

Name: FDA 510(k) clearance K803250
Creator: U.S. Food and Drug Administration
Published: 1981-02-12

Substantially Equivalent

Plastic Applications, Inc.

FDA 510(k) clearance K803250 for TASSAWAY, Substantially Equivalent on 1981-02-12. Applicant: Plastic Applications, Inc.. Device class: 2.

Clearance details

Applicant: Plastic Applications, Inc.
Product code: Code HHE
Device class: Class 2
Regulation: 21 CFR 884.5400
Advisory panel: Obstetrics/Gynecology
Date received: 1980-12-23
Decision date: 1981-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code HHE

product code HHE

Injury: 344
Total: 344

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.