AMSURE BLADDER IRRIGATION SET— 510(k) K070873

Name: FDA 510(k) clearance K070873
Creator: U.S. Food and Drug Administration
Published: 2007-12-19

Substantially Equivalent

Amsino Intl., Inc.

FDA 510(k) clearance K070873 for AMSURE BLADDER IRRIGATION SET, Substantially Equivalent on 2007-12-19. Applicant: Amsino Intl., Inc.. Device class: 2.

Clearance details

Applicant: Amsino Intl., Inc.
Product code: Code LJH
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2007-03-29
Decision date: 2007-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

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