Geomed Vascular Dilators— 510(k) K183438

Name: FDA 510(k) clearance K183438
Creator: U.S. Food and Drug Administration
Published: 2019-09-03

Substantially Equivalent

Geomed Medizin-Technik GmbH & Co.

FDA 510(k) clearance K183438 for Geomed Vascular Dilators, Substantially Equivalent on 2019-09-03. Applicant: Geomed Medizin-Technik GmbH & Co.. Device class: 2.

Clearance details

Applicant: Geomed Medizin-Technik GmbH & Co.
Product code: Code DWP
Device class: Class 2
Regulation: 21 CFR 870.4475
Advisory panel: Cardiovascular
Date received: 2018-12-12
Decision date: 2019-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

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