SITE STRIP— 510(k) K843200

Substantially Equivalent

E-Med Corp.

FDA 510(k) clearance K843200 for SITE STRIP, Substantially Equivalent on 1985-03-12. Applicant: E-Med Corp..

Clearance details

Applicant: E-Med Corp.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 1984-08-14
Decision date: 1985-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

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.