K161050

Substantially Equivalent

ACTABOND Topical Skin Adhesive

Applicant: Bergen Medical Products, Inc.
Product code: MPN
Advisory panel: General, Plastic Surgery
Date received: 2016-04-14
Decision date: 2016-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedar Knolls, NJ, US

Adverse events under product code MPN

product code MPN

Injury: 856
Other: 1
Total: 857

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.