AMUKIN 50% - AIRSPRAY(R)— 510(k) K885037

Substantially Equivalent

Bernard J. Cooney, P.A.

FDA 510(k) clearance K885037 for AMUKIN 50% - AIRSPRAY(R), Substantially Equivalent on 1990-10-19. Applicant: Bernard J. Cooney, P.A..

Clearance details

Applicant: Bernard J. Cooney, P.A.
Product code: Code FKO
Advisory panel: Gastroenterology, Urology
Date received: 1988-12-05
Decision date: 1990-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chevy Chase, MD, US

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Adverse events under product code FKO

product code FKO

Other: 1
Total: 1

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.