CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET— 510(k) K813084

Name: FDA 510(k) clearance K813084
Creator: U.S. Food and Drug Administration
Published: 1981-12-31

Substantially Equivalent

Burron Medical Products, Inc.

FDA 510(k) clearance K813084 for CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET, Substantially Equivalent on 1981-12-31. Applicant: Burron Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Burron Medical Products, Inc.
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1981-11-02
Decision date: 1981-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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