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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 K890518
Device Name SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM
Applicant
Harbor Medical Devices, Inc.
25 Drydock Ave.
Boston,  MA  02210
Applicant Contact JOSHUA TOLKOFF
Correspondent
Harbor Medical Devices, Inc.
25 Drydock Ave.
Boston,  MA  02210
Correspondent Contact JOSHUA TOLKOFF
Regulation Number880.5965
Classification Product Code
LJT  
Date Received02/02/1989
Decision Date 04/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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