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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 K882190
Device Name S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM
Applicant
Harbor Medical Devices, Inc.
25 Drydock Ave.
Boston,  MA  02210 -3912
Applicant Contact JOSHUA TOLKOFF
Correspondent
Harbor Medical Devices, Inc.
25 Drydock Ave.
Boston,  MA  02210 -3912
Correspondent Contact JOSHUA TOLKOFF
Regulation Number880.5965
Classification Product Code
LJT  
Date Received05/24/1988
Decision Date 06/09/1988
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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