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

Name: FDA 510(k) clearance K885037
Creator: U.S. Food and Drug Administration
Published: 1990-10-19

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.. Device class: 2.

Clearance details

Applicant: Bernard J. Cooney, P.A.
Product code: Code FKO
Device class: Class 2
Regulation: 21 CFR 876.5630
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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K974570 — PERITONEAL DIALYSIS CATHETER CONNECTOR1998-02-27
K910787 — TITANIUM CONNECTOR (2 PART)1991-08-15
K874650 — PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)1987-12-09
K872221 — DIALY-NATE SET & DIALY-NATE CATHETER1987-10-13

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.