SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS— 510(k) K981286

Name: FDA 510(k) clearance K981286
Creator: U.S. Food and Drug Administration
Published: 1998-06-19

Substantially Equivalent

Armm, Inc.

FDA 510(k) clearance K981286 for SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS, Substantially Equivalent on 1998-06-19. Applicant: Armm, Inc.. Device class: 2.

Clearance details

Applicant: Armm, Inc.
Product code: Code KDH
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1998-04-08
Decision date: 1998-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington Beach, CA, 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.