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510(k) K091181

LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS by Smiths Medical MD, Inc. — Product Code MRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2009
Date Received
April 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Smiths Medical MD, Inc.

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  • K111386 — MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFE (August 29, 2011)
  • K101180 — GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MOD (August 3, 2010)
  • K082783 — CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE (December 17, 2008)
  • K081156 — CADD MEDICATION CASSETTE RESERVOIR (July 18, 2008)
  • K080743 — LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP (April 25, 2008)
  • K072144 — CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE (March 7, 2008)
  • K072955 — CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CAR (February 13, 2008)
  • K072657 — POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS A (December 14, 2007)
  • K072059 — GRIPPER MICRO NEEDLE (November 1, 2007)

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