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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name port & catheter, implanted, subcutaneous, intravascular
510(k) Number K190559
Device Name SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
Applicant
AngioDynamics, Inc.
26 Forest Street
Marlborough,  MA  01752
Applicant Contact Vidyalakshmi Jayaraman
Correspondent
AngioDynamics, Inc.
26 Forest Street
Marlborough,  MA  01752
Correspondent Contact Vidyalakshmi Jayaraman
Regulation Number880.5965
Classification Product Code
LJT  
Date Received03/05/2019
Decision Date 05/22/2020
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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