ASK-300— 510(k) K882977

Substantially Equivalent

Medical Repackers Co.

FDA 510(k) clearance K882977 for ASK-300, Substantially Equivalent on 1989-01-05. Applicant: Medical Repackers Co..

Clearance details

Applicant: Medical Repackers Co.
Product code: Code DQR
Advisory panel: Cardiovascular
Date received: 1988-07-15
Decision date: 1989-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Payne, AL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQR

product code DQR

Death: 2
Total: 2

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.