MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)— 510(k) K972119

Name: FDA 510(k) clearance K972119
Creator: U.S. Food and Drug Administration
Published: 1998-02-02

Substantially Equivalent

Medovations, Inc.

FDA 510(k) clearance K972119 for MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX), Substantially Equivalent on 1998-02-02. Applicant: Medovations, Inc.. Device class: 2.

Clearance details

Applicant: Medovations, Inc.
Product code: Code FAT
Device class: Class 2
Regulation: 21 CFR 876.5365
Advisory panel: Gastroenterology, Urology
Date received: 1997-06-05
Decision date: 1998-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Germantown, WI, US

Download summary PDF View on FDA.gov ↗

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