K791526

Substantially Equivalent

HOLLISTER STOMA POUCH SKIN BARRIER

Applicant: Hollister, Inc.
Product code: EXB
Advisory panel: Gastroenterology, Urology
Date received: 1979-08-10
Decision date: 1979-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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.