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510(k) K090300

MODIFICATION TO AUTOFUSER by Ace Medical Us, LLC — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2009
Date Received
February 6, 2009
Clearance Type
Special
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

  • K060258 — AUTOFUSER (May 30, 2006)

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