SPYGLASS IRRIGATION SYSTEM— 510(k) K063700

Name: FDA 510(k) clearance K063700
Creator: U.S. Food and Drug Administration
Published: 2007-02-08

Substantially Equivalent

Medical Scientific, Inc.

FDA 510(k) clearance K063700 for SPYGLASS IRRIGATION SYSTEM, Substantially Equivalent on 2007-02-08. Applicant: Medical Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Medical Scientific, Inc.
Product code: Code LJH
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2006-12-13
Decision date: 2007-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taunton, MA, US

Download summary PDF View on FDA.gov ↗

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