EDWARDS-WALLACE BOURNE HALL CATHETER— 510(k) K910577

Name: FDA 510(k) clearance K910577
Creator: U.S. Food and Drug Administration
Published: 1991-05-09

Substantially Equivalent

Marlo Surgical Technology

FDA 510(k) clearance K910577 for EDWARDS-WALLACE BOURNE HALL CATHETER, Substantially Equivalent on 1991-05-09. Applicant: Marlo Surgical Technology. Device class: 2.

Clearance details

Applicant: Marlo Surgical Technology
Product code: Code MFD
Device class: Class 2
Regulation: 21 CFR 884.5250
Advisory panel: Obstetrics/Gynecology
Date received: 1991-02-11
Decision date: 1991-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Willoughby, OH, US

Download summary PDF View on FDA.gov ↗

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