ANEURYSM CLIPS— 510(k) K013136

Substantially Equivalent

Gistlstrasse

FDA 510(k) clearance K013136 for ANEURYSM CLIPS, Substantially Equivalent on 2001-11-26. Applicant: Gistlstrasse. Device class: 2.

Clearance details

Applicant: Gistlstrasse
Product code: Code HCH
Device class: Class 2
Regulation: 21 CFR 882.5200
Advisory panel: Neurology
Date received: 2001-09-19
Decision date: 2001-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pullach, 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.