PHASEAL PROTECTOR P14, P21, P28 AND P50— 510(k) K090634

Substantially Equivalent

Carmel Pharma Ab.

FDA 510(k) clearance K090634 for PHASEAL PROTECTOR P14, P21, P28 AND P50, Substantially Equivalent on 2009-03-23. Applicant: Carmel Pharma Ab..

Clearance details

Applicant: Carmel Pharma Ab.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2009-03-09
Decision date: 2009-03-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Gothenburg, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.