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510(k) K963583

MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE by Medimop Medical Projects, Ltd. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1996
Date Received
September 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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  • K031861 — MIX2VIAL TRANSFER DEVICE (July 29, 2003)
  • K001831 — NEEDLELESS TRANSFER DEVICE (July 11, 2000)

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