20G x 5/8 Pro-Lock CT Safety Infusion Set— 510(k) K171333

Name: FDA 510(k) clearance K171333
Creator: U.S. Food and Drug Administration
Published: 2017-07-18

Substantially Equivalent

Medcomp (Dba Medical Components, Inc.)

FDA 510(k) clearance K171333 for 20G x 5/8 Pro-Lock CT Safety Infusion Set, Substantially Equivalent on 2017-07-18. Applicant: Medcomp (Dba Medical Components, Inc.). Device class: 2.

Clearance details

Applicant: Medcomp (Dba Medical Components, Inc.)
Product code: Code PTI
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2017-05-08
Decision date: 2017-07-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Harleysville, PA, US

Download summary PDF View on FDA.gov ↗

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