ORS MODEL 6000 ENDOSCOPE HOLDER— 510(k) K051979

Name: FDA 510(k) clearance K051979
Creator: U.S. Food and Drug Administration
Published: 2005-08-30

Substantially Equivalent

O.R. Solutions, Inc.

FDA 510(k) clearance K051979 for ORS MODEL 6000 ENDOSCOPE HOLDER, Substantially Equivalent on 2005-08-30. Applicant: O.R. Solutions, Inc.. Device class: 2.

Clearance details

Applicant: O.R. Solutions, Inc.
Product code: Code OCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2005-07-21
Decision date: 2005-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

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