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510(k) K160503

Vented Vial Adapter Transfer Device - 13mm by Medimop Medical Projects, Ltd. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2016
Date Received
February 24, 2016
Clearance Type
Special
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

Other clearances by Medimop Medical Projects, Ltd.

  • K140730 — VIAL2BAG DIRECT CONNECT (June 12, 2014)
  • K130179 — MP VIAL ADAPTER 13MM (August 8, 2013)
  • K132040 — VIAL CONNECTOR 13MM CLOSED COLLAR (July 31, 2013)
  • K122023 — MIXJECT WITH SPRAY HEAD (October 4, 2012)
  • K072511 — SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM (December 13, 2007)
  • K072759 — VIAL2BAG (December 13, 2007)
  • K062482 — VENTED VIAL ADAPTER TRANSFER DEVICE (November 3, 2006)
  • K031861 — MIX2VIAL TRANSFER DEVICE (July 29, 2003)
  • K001831 — NEEDLELESS TRANSFER DEVICE (July 11, 2000)
  • K001293 — MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHAB (May 5, 2000)

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