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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K900998
Device Name INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE
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 Number870.1250
Classification Product Code
DQY  
Date Received03/01/1990
Decision Date 08/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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