O.R. CONCEPTS' IRRIGATING KITTNER— 510(k) K923818

Name: FDA 510(k) clearance K923818
Creator: U.S. Food and Drug Administration
Published: 1993-04-07

Substantially Equivalent

O.R. Concepts, Inc.

FDA 510(k) clearance K923818 for O.R. CONCEPTS' IRRIGATING KITTNER, Substantially Equivalent on 1993-04-07. Applicant: O.R. Concepts, Inc.. Device class: 2.

Clearance details

Applicant: O.R. Concepts, Inc.
Product code: Code FGS
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1992-07-30
Decision date: 1993-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roanoke, TX, US

Download summary PDF View on FDA.gov ↗

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