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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 K131694
Device Name NMI PORT II CATHETER
Applicant
Navilyst Medical, Inc.
26 Forest St.
Marlborough,  MA  01752
Applicant Contact BRANDON M BRACKETT
Correspondent
Navilyst Medical, Inc.
26 Forest St.
Marlborough,  MA  01752
Correspondent Contact BRANDON M BRACKETT
Regulation Number880.5965
Classification Product Code
LJT  
Date Received06/10/2013
Decision Date 08/08/2013
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
Recalls CDRH Recalls
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