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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K080328
Device Name MPS ACACIA ENTERAL FEEDING TUBE
Applicant
MPS ACACIA
785 CHALLENGER ST.
BREA,  CA  92821
Applicant Contact FERGIE FERGUSON
Correspondent
MPS ACACIA
785 CHALLENGER ST.
BREA,  CA  92821
Correspondent Contact FERGIE FERGUSON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received02/07/2008
Decision Date 05/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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