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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 K122834
Device Name POLYSITE IMPLANTABLE INFUSION PORTS
Applicant
Perouse Medical
Rte. Du Manoir
Ivry-Le-Temple
France,  FR 60173
Applicant Contact Isabelle Jeanty
Correspondent
Perouse Medical
Rte. Du Manoir
Ivry-Le-Temple
France,  FR 60173
Correspondent Contact Isabelle Jeanty
Regulation Number880.5965
Classification Product Code
LJT  
Subsequent Product Code
OKE  
Date Received09/17/2012
Decision Date 12/11/2013
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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