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510(k) K973899

UNIFINE PENTIPS by Owen Mumford USA, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1997
Date Received
October 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Owen Mumford USA, Inc.

  • K013362 — AUTOJECT 2 (November 13, 2001)
  • K993385 — AUTOJET 2 (NON-FIXED NEEDLE TYPE) (November 10, 1999)
  • K983994 — UNIFINE (January 8, 1999)
  • K983974 — OWEN MUMFORD 3ML AUTOPEN (December 21, 1998)
  • K982275 — RAPPORT V.T.D. (December 4, 1998)
  • K983045 — AMIELLE (November 25, 1998)
  • K971443 — RAPPORT V.T.D. (September 26, 1997)
  • K953735 — AUTOJECT MINI (November 8, 1995)
  • K945660 — AUTOJECT 2 (August 11, 1995)

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