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510(k) K945873

HYPEX(TM) JET INJECTOR by Equidyne Systems, Inc. — Product Code KZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1995
Date Received
December 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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  • K003864 — INJEX 50 SYSTEM (March 6, 2001)

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