DFINER UROLOGICAL CATHETER— 510(k) K013360

Name: FDA 510(k) clearance K013360
Creator: U.S. Food and Drug Administration
Published: 2002-02-20

Substantially Equivalent

Neoseed Technology,Llc

FDA 510(k) clearance K013360 for DFINER UROLOGICAL CATHETER, Substantially Equivalent on 2002-02-20. Applicant: Neoseed Technology,Llc. Device class: 2.

Clearance details

Applicant: Neoseed Technology,Llc
Product code: Code FGI
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2001-10-10
Decision date: 2002-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newburyport, MA, US

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