POLYDERM PEC(TM), POROUS ELASTIC COVER— 510(k) K880964

Substantially Equivalent for Some Indications

Laivan Corp.

FDA 510(k) clearance K880964 for POLYDERM PEC(TM), POROUS ELASTIC COVER, Substantially Equivalent for Some Indications on 1988-03-17. Applicant: Laivan Corp..

Clearance details

Applicant: Laivan Corp.
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1988-03-08
Decision date: 1988-03-17
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: East Rockaway, NY, US

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Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.