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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K903906
Device Name PERCUTANEOUS CATHETER INTRODUCER KIT
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 Number870.1340
Classification Product Code
DYB  
Date Received08/23/1990
Decision Date 09/26/1990
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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