MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING— 510(k) K131517

Name: FDA 510(k) clearance K131517
Creator: U.S. Food and Drug Administration
Published: 2013-08-02

Substantially Equivalent

Medrad, Inc. / Bayer Medical Care, Inc.

FDA 510(k) clearance K131517 for MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING, Substantially Equivalent on 2013-08-02. Applicant: Medrad, Inc. / Bayer Medical Care, Inc.. Device class: 2.

Clearance details

Applicant: Medrad, Inc. / Bayer Medical Care, Inc.
Product code: Code FPK
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2013-05-28
Decision date: 2013-08-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianola, PA, US

Download summary PDF View on FDA.gov ↗

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