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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 K120209
Device Name PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE
Applicant
AMERICAN I.V. PRODUCTS, INC.
7485 SHIPLEY AVE.
HARMANS,  MD  21077
Applicant Contact MAJDI SHOMALI
Correspondent
AMERICAN I.V. PRODUCTS, INC.
7485 SHIPLEY AVE.
HARMANS,  MD  21077
Correspondent Contact MAJDI SHOMALI
Regulation Number880.5725
Classification Product Code
MRZ  
Date Received01/24/2012
Decision Date 04/12/2012
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
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