SWEEN-A-PEEL PERISTOMAL WAFERS— 510(k) K840723

Substantially Equivalent

Sween Corp.

FDA 510(k) clearance K840723 for SWEEN-A-PEEL PERISTOMAL WAFERS, Substantially Equivalent on 1984-05-07. Applicant: Sween Corp..

Clearance details

Applicant: Sween Corp.
Product code: Code EXB
Advisory panel: Gastroenterology, Urology
Date received: 1984-02-21
Decision date: 1984-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EXB

product code EXB

Injury: 145
Total: 145

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.