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510(k) K962625

VITAJET by Vitajet Corp. — Product Code KZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1996
Date Received
July 5, 1996
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

Other clearances by Vitajet Corp.

  • K945548 — MEDIVAX (November 20, 1995)
  • K924447 — VITAPEN (September 27, 1993)

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