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510(k) K020786

INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM by Rosch AG Medizintechnic — Product Code KZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2002
Date Received
March 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Injector, Fluid, Non-Electrically Powered
Device Class
Class II
Regulation Number
880.5430
Review Panel
HO
Submission Type

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