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510(k) K082212

SYRINGE WITH HANDI-FIL by Mallinckrodt Inc., Liebel-Flarsheim Business — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2009
Date Received
August 6, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

Other clearances by Mallinckrodt Inc., Liebel-Flarsheim Business

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  • K063503 — OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION (April 27, 2007)
  • K042744 — OPTIV ANTAGE DH POWER INJECTION SYSTEM (November 30, 2004)
  • K031339 — OPTIBOLUS (July 11, 2003)
  • K022116 — ELPH INJECTION SYSTEM (July 26, 2002)
  • K984088 — OPTISTAR MR INJECTOR SYSTEM (December 6, 1999)
  • K963071 — ANGIOMAT ILLUMENA (September 23, 1997)

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