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510(k) K003741

JET SYRINGE MODEL-100500 by Equidyne Systems, Inc. — Product Code KZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2001
Date Received
December 4, 2000
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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  • K945873 — HYPEX(TM) JET INJECTOR (August 18, 1995)

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