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510(k) K895290

CHEMO-SPIKE RECONSTITUTION DEVICE by The Medi-Dose Group — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1989
Date Received
August 25, 1989
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

  • K952242 — TRANSFEER SPIKE II (September 15, 1995)
  • 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)
  • 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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