TRANS/R - FP(3)— 510(k) K900016

Name: FDA 510(k) clearance K900016
Creator: U.S. Food and Drug Administration
Published: 1990-06-11

Substantially Equivalent

CIVCO Medical Instruments Co., Inc.

FDA 510(k) clearance K900016 for TRANS/R - FP(3), Substantially Equivalent on 1990-06-11. Applicant: CIVCO Medical Instruments Co., Inc.. Device class: 1.

Clearance details

Applicant: CIVCO Medical Instruments Co., Inc.
Product code: Code FCY
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1990-01-02
Decision date: 1990-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalona, IA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.