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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 K881884
Device Name HARBOR CENTRAL VENOUS CATHETER
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 Number870.1300
Classification Product Code
DQR  
Date Received05/04/1988
Decision Date 07/28/1988
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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