MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM— 510(k) K071832

Name: FDA 510(k) clearance K071832
Creator: U.S. Food and Drug Administration
Published: 2007-09-18

Substantially Equivalent

Medical Scientific, Inc.

FDA 510(k) clearance K071832 for MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM, Substantially Equivalent on 2007-09-18. 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: 2007-07-03
Decision date: 2007-09-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Taunton, MA, US

Download summary PDF View on FDA.gov ↗

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