AN-10S ANDERSEN TUBE WITH STYLET— 510(k) K935688

Name: FDA 510(k) clearance K935688
Creator: U.S. Food and Drug Administration
Published: 1994-12-30

Substantially Equivalent

H.W. Andersen Products, Inc.

FDA 510(k) clearance K935688 for AN-10S ANDERSEN TUBE WITH STYLET, Substantially Equivalent on 1994-12-30. Applicant: H.W. Andersen Products, Inc.. Device class: 2.

Clearance details

Applicant: H.W. Andersen Products, Inc.
Product code: Code BSS
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1993-11-29
Decision date: 1994-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chapel Hill, NC, US

Download summary PDF View on FDA.gov ↗

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