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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K901247
Device Name TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES
Applicant
Intec Medical, Inc.
P.O. Box 2186
35a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact KENNETH A SPECTOR
Correspondent
Intec Medical, Inc.
P.O. Box 2186
35a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact KENNETH A SPECTOR
Regulation Number870.1240
Classification Product Code
DYG  
Date Received03/15/1990
Decision Date 07/31/1990
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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