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FDA 510(k), K111517, PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
FDA 510(k), K111517, PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
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510(K) Number: K111517
Device Name: PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
Manufacturer: PHARMAJET, INC.
Device Classification Name: injector, fluid, non-electrically powered
Regulation Number: 880.5430
Classification Product Code: KZE
Date Received: 06/02/2011
Decision Date: 07/27/2011
Regulation Medical Specialty: General Hospital
Device Name: PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
Manufacturer: PHARMAJET, INC.
Device Classification Name: injector, fluid, non-electrically powered
Regulation Number: 880.5430
Classification Product Code: KZE
Date Received: 06/02/2011
Decision Date: 07/27/2011
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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