POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER— 510(k) K880206

Substantially Equivalent for Some Indications

Laivan Corp.

FDA 510(k) clearance K880206 for POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER, Substantially Equivalent for Some Indications on 1988-03-11. Applicant: Laivan Corp..

Clearance details

Applicant: Laivan Corp.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 1988-01-15
Decision date: 1988-03-11
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: East Rockaway, NY, US

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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.