PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI

Injector, Fluid, Non-electrically Powered

PHARMAJET, INC.

The following data is part of a premarket notification filed by Pharmajet, Inc. with the FDA for Pharmajet Stratis 0.5 Ml Needle-free Injection System Model 501-01, Stratis Injector Catalog 501-10, Stratis Reset Stati.

Pre-market Notification Details

• Device ID: K111517
• 510k Number: K111517
• Device Name: PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
• Classification: Injector, Fluid, Non-electrically Powered
• Applicant: PHARMAJET, INC. 400 CORORATE CIRCLE, SUITE N Golden, CO 80401
• Contact: Michael J Ryan
• Correspondent: Michael J Ryan; PHARMAJET, INC. 400 CORORATE CIRCLE, SUITE N Golden, CO 80401
• Product Code: KZE
• CFR Regulation Number: 880.5430 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-02
• Decision Date: 2011-07-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00856457003374	K111517	000
00856457003367	K111517	000
00856457003312	K111517	000
00856457003305	K111517	000
00856457003213	K111517	000
00856457003206	K111517	000