STERILE FOLEY CATHETER— 510(k) K890310

Name: FDA 510(k) clearance K890310
Creator: U.S. Food and Drug Administration
Published: 1989-11-30

Substantially Equivalent

Kosan Far East Ent. , Ltd.

FDA 510(k) clearance K890310 for STERILE FOLEY CATHETER, Substantially Equivalent on 1989-11-30. Applicant: Kosan Far East Ent. , Ltd.. Device class: 2.

Clearance details

Applicant: Kosan Far East Ent. , Ltd.
Product code: Code EYC
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1989-01-23
Decision date: 1989-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, TW

Download summary PDF View on FDA.gov ↗

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