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510(k) K952242

TRANSFEER SPIKE II by The Medi-Dose Group — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
May 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by The Medi-Dose Group

  • K942625 — 1.2 MICRON AIR ELIMINATING FILTER (October 7, 1994)
  • K900651 — TS-1800 MEDICATION TRANSFER SPIKE (May 7, 1990)
  • K895291 — IV DISPESNSING SPIKE (December 27, 1989)
  • K895290 — CHEMO-SPIKE RECONSTITUTION DEVICE (December 27, 1989)
  • K896291 — INJECTION PORT II --- FOR INTERMITTENT INJECTION (December 1, 1989)
  • K895419 — DISPOSABLE DISC FILTER (November 24, 1989)
  • K892429 — INJECTION PORT FOR---INTERMITTENT INJECTION (July 25, 1989)
  • K892430 — DISPOSABLE DISC FILTER (July 14, 1989)
  • K892428 — COMBI-CAP (July 14, 1989)

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