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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Catheter
510(k) Number K884628
Device Name HARBORIN CENTRAL VENOUS CATHETER
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 Number870.1300
Classification Product Code
DQR  
Date Received11/07/1988
Decision Date 05/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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