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510(k) K953474

IV START KIT by Medikmark, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1995
Date Received
July 24, 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 Medikmark, Inc.

  • K923960 — UPPER EXTERMITY DRAPE KIT (October 7, 1994)
  • K921733 — TRACHEOSTOMY CARE TRAY (June 15, 1994)
  • K921730 — C-SECTION PACK (June 15, 1994)
  • K921732 — MINOR LAP SET (June 15, 1994)
  • K920340 — SUTURE REMOVAL KIT (April 23, 1992)
  • K920341 — LACERATION TRAYS (April 23, 1992)
  • K920339 — DRESSING CHANGE TRAY (April 23, 1992)

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