KIT PAK WET SALINE DRESSING— 510(k) K942959

Substantially Equivalent for Some Indications

Kit Pak, Inc.

FDA 510(k) clearance K942959 for KIT PAK WET SALINE DRESSING, Substantially Equivalent for Some Indications on 1995-02-14. Applicant: Kit Pak, Inc..

Clearance details

Applicant: Kit Pak, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1994-06-23
Decision date: 1995-02-14
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Elk Grove Village, IL, 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.