POLYDERM A+B(TM)— 510(k) K880153

Substantially Equivalent for Some Indications

Laivan Corp.

FDA 510(k) clearance K880153 for POLYDERM A+B(TM), Substantially Equivalent for Some Indications on 1988-04-13. Applicant: Laivan Corp..

Clearance details

Applicant: Laivan Corp.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 1988-01-13
Decision date: 1988-04-13
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: East Rockaway, NY, 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.