VacLok AT Vacuum Syringe— 510(k) K163597

Name: FDA 510(k) clearance K163597
Creator: U.S. Food and Drug Administration
Published: 2017-07-27

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K163597 for VacLok AT Vacuum Syringe, Substantially Equivalent on 2017-07-27. Applicant: Merit Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code PUR
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2016-12-21
Decision date: 2017-07-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

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