MANAN GWI GUIDE WIRE INTRODUCER— 510(k) K851834

Name: FDA 510(k) clearance K851834
Creator: U.S. Food and Drug Administration
Published: 1985-07-11

Substantially Equivalent

Manan Manufacturing Co., Inc.

FDA 510(k) clearance K851834 for MANAN GWI GUIDE WIRE INTRODUCER, Substantially Equivalent on 1985-07-11. Applicant: Manan Manufacturing Co., Inc.. Device class: 1.

Clearance details

Applicant: Manan Manufacturing Co., Inc.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1985-04-26
Decision date: 1985-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, US

Download summary PDF View on FDA.gov ↗

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