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510(k) K060258

AUTOFUSER by Ace Medical Us, LLC — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2006
Date Received
February 1, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Ace Medical Us, LLC

  • K090300 — MODIFICATION TO AUTOFUSER (April 30, 2009)

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  • K131247 — MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (August 14, 2013)
  • K090300 — MODIFICATION TO AUTOFUSER (April 30, 2009)
  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)
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