ANGIOLAZ ANGIOSCOPE CATHETER— 510(k) K913129

Substantially Equivalent

Angiolaz, Inc.

FDA 510(k) clearance K913129 for ANGIOLAZ ANGIOSCOPE CATHETER, Substantially Equivalent on 1991-12-27. Applicant: Angiolaz, Inc.. Device class: 2.

Clearance details

Applicant: Angiolaz, Inc.
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1991-07-16
Decision date: 1991-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockingham, VT, 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.