STOMACH, GASTRO-ENTEROSTOMY— 510(k) K902421

Name: FDA 510(k) clearance K902421
Creator: U.S. Food and Drug Administration
Published: 1990-11-20

Substantially Equivalent

Gainor Medical Europe, Ltd.

FDA 510(k) clearance K902421 for STOMACH, GASTRO-ENTEROSTOMY, Substantially Equivalent on 1990-11-20. Applicant: Gainor Medical Europe, Ltd.. Device class: 2.

Clearance details

Applicant: Gainor Medical Europe, Ltd.
Product code: Code KDH
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1990-05-31
Decision date: 1990-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcdonough, GA, US

Download summary PDF View on FDA.gov ↗

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