MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM— 510(k) K830438

Name: FDA 510(k) clearance K830438
Creator: U.S. Food and Drug Administration
Published: 1983-03-17

Substantially Equivalent

Medcomp

FDA 510(k) clearance K830438 for MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM, Substantially Equivalent on 1983-03-17. Applicant: Medcomp. Device class: 2.

Clearance details

Applicant: Medcomp
Product code: Code LFJ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1983-02-09
Decision date: 1983-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.