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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, infusion, elastomeric
510(k) Number K060258
Device Name AUTOFUSER
Applicant
ACE MEDICAL US, LLC
9102 TURFWAY BEND DR.
POWELL,  OH  43065 -8497
Applicant Contact ANDY LAMBORNE
Correspondent
ACE MEDICAL US, LLC
9102 TURFWAY BEND DR.
POWELL,  OH  43065 -8497
Correspondent Contact ANDY LAMBORNE
Regulation Number880.5725
Classification Product Code
MEB  
Date Received02/01/2006
Decision Date 05/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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