ELMED PNEUMOPERITONEUM NEEDLES— 510(k) K943624

Name: FDA 510(k) clearance K943624
Creator: U.S. Food and Drug Administration
Published: 1994-08-10

Substantially Equivalent

Henke-Sass, Wolf GmbH

FDA 510(k) clearance K943624 for ELMED PNEUMOPERITONEUM NEEDLES, Substantially Equivalent on 1994-08-10. Applicant: Henke-Sass, Wolf GmbH. Device class: 2.

Clearance details

Applicant: Henke-Sass, Wolf GmbH
Product code: Code FHO
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1994-07-26
Decision date: 1994-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

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