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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K132011
Device Name APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET
Applicant
Aea Srl
Via Fiume 16
Angeli Di Rosora,  IT 60030
Applicant Contact MICHELE MENGONI
Correspondent
Aea Srl
Via Fiume 16
Angeli Di Rosora,  IT 60030
Correspondent Contact MICHELE MENGONI
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
LHI  
Date Received07/01/2013
Decision Date 03/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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