INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT— 510(k) K960173

Name: FDA 510(k) clearance K960173
Creator: U.S. Food and Drug Administration
Published: 1996-06-27

Substantially Equivalent

Gabriel Medical, Inc.

FDA 510(k) clearance K960173 for INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT, Substantially Equivalent on 1996-06-27. Applicant: Gabriel Medical, Inc.. Device class: 2.

Clearance details

Applicant: Gabriel Medical, Inc.
Product code: Code FAT
Device class: Class 2
Regulation: 21 CFR 876.5365
Advisory panel: Gastroenterology, Urology
Date received: 1996-01-16
Decision date: 1996-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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