PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI— 510(k) K111517

Name: FDA 510(k) clearance K111517
Creator: U.S. Food and Drug Administration
Published: 2011-07-27

Substantially Equivalent

Pharmajet, Inc.

FDA 510(k) clearance K111517 for PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI, Substantially Equivalent on 2011-07-27. Applicant: Pharmajet, Inc.. Device class: 2.

Clearance details

Applicant: Pharmajet, Inc.
Product code: Code KZE
Device class: Class 2
Regulation: 21 CFR 880.5430
Advisory panel: General Hospital
Date received: 2011-06-02
Decision date: 2011-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

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