ALLEGIANCE KWIK HEAT WARM PERINEAL PACK— 510(k) K973770

Substantially Equivalent

Allegiance Healthcare Corp.

FDA 510(k) clearance K973770 for ALLEGIANCE KWIK HEAT WARM PERINEAL PACK, Substantially Equivalent on 1997-11-13. Applicant: Allegiance Healthcare Corp..

Clearance details

Applicant: Allegiance Healthcare Corp.
Product code: Code IMD
Advisory panel: Physical Medicine
Date received: 1997-10-02
Decision date: 1997-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgraw Park, IL, US

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Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

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.