SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN— 510(k) K992363

Substantially Equivalent

Euromed, Inc.

FDA 510(k) clearance K992363 for SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN, Substantially Equivalent on 1999-08-12. Applicant: Euromed, Inc..

Clearance details

Applicant: Euromed, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1999-07-15
Decision date: 1999-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.