BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)— 510(k) K970110

Name: FDA 510(k) clearance K970110
Creator: U.S. Food and Drug Administration
Published: 1997-02-19

Substantially Equivalent

Bard Medical Div.

FDA 510(k) clearance K970110 for BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019), Substantially Equivalent on 1997-02-19. Applicant: Bard Medical Div.. Device class: 2.

Clearance details

Applicant: Bard Medical Div.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1997-01-13
Decision date: 1997-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

Download summary PDF View on FDA.gov ↗

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