PULLER OPTION FOR ETUDE(TM)— 510(k) K914891

Name: FDA 510(k) clearance K914891
Creator: U.S. Food and Drug Administration
Published: 1992-01-07

Substantially Equivalent

Dantec Medical, Inc.

FDA 510(k) clearance K914891 for PULLER OPTION FOR ETUDE(TM), Substantially Equivalent on 1992-01-07. Applicant: Dantec Medical, Inc.. Device class: 2.

Clearance details

Applicant: Dantec Medical, Inc.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-31
Decision date: 1992-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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