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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Pump, Infusion
510(k) Number K142333
Device Name SMART LABEL, PROPOFOL
Applicant
American I.V. Products, Inc. Dba Aiv, Inc.
7485 Shipley Ave.
Harmans,  MD  21077
Applicant Contact SHANNON HOUCHEN
Correspondent
American I.V. Products, Inc. Dba Aiv, Inc.
7485 Shipley Ave.
Harmans,  MD  21077
Correspondent Contact SHANNON HOUCHEN
Regulation Number880.5725
Classification Product Code
MRZ  
Date Received08/21/2014
Decision Date 12/18/2014
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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