SCOPE INTRODUCER MODEL 7400— 510(k) K093329

Name: FDA 510(k) clearance K093329
Creator: U.S. Food and Drug Administration
Published: 2010-02-16

Substantially Equivalent

N.M. Beale Co., Inc.

FDA 510(k) clearance K093329 for SCOPE INTRODUCER MODEL 7400, Substantially Equivalent on 2010-02-16. Applicant: N.M. Beale Co., Inc.. Device class: 2.

Clearance details

Applicant: N.M. Beale Co., Inc.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2009-10-26
Decision date: 2010-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ayer, MA, US

Download summary PDF View on FDA.gov ↗

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