Pro-Lock CT Safety Infusion Set— 510(k) K162271

Name: FDA 510(k) clearance K162271
Creator: U.S. Food and Drug Administration
Published: 2017-04-26

Substantially Equivalent

Medcomp (Medical Components, Inc.)

FDA 510(k) clearance K162271 for Pro-Lock CT Safety Infusion Set, Substantially Equivalent on 2017-04-26. Applicant: Medcomp (Medical Components, Inc.). Device class: 2.

Clearance details

Applicant: Medcomp (Medical Components, Inc.)
Product code: Code PTI
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2016-08-12
Decision date: 2017-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harleysville, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.