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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, Enteral
510(k) Number K011868
Device Name ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS
Applicant
Debio Tech SA
16787 Bernardo Center Dr.,
Suite A-1
San Diego,  CA  92128
Applicant Contact SEAN CURRY
Correspondent
Debio Tech SA
16787 Bernardo Center Dr.,
Suite A-1
San Diego,  CA  92128
Correspondent Contact SEAN CURRY
Regulation Number880.5725
Classification Product Code
LZH  
Date Received06/14/2001
Decision Date 09/04/2001
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
Predetermined Change
Control Plan Authorized		 No
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