SITZMARKS— 510(k) K881609

Substantially Equivalent

Lafayette Pharmacal, Inc.

FDA 510(k) clearance K881609 for SITZMARKS, Substantially Equivalent on 1988-07-08. Applicant: Lafayette Pharmacal, Inc..

Clearance details

Applicant: Lafayette Pharmacal, Inc.
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 1988-04-12
Decision date: 1988-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, IN, US

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Adverse events under product code FFX

product code FFX

Other: 1
Total: 1

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.