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510(k) K895419

DISPOSABLE DISC FILTER by The Medi-Dose Group — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1989
Date Received
September 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
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)
  • K895290 — CHEMO-SPIKE RECONSTITUTION DEVICE (December 27, 1989)
  • K896291 — INJECTION PORT II --- FOR INTERMITTENT INJECTION (December 1, 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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