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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 K900756
Device Name ITC INTRODUCER CATHETER
Applicant
Interventional Therapeutics Corp.
385 Oyster Pt. Blvd., Suite #6
South San Francisco,  CA  94080
Applicant Contact JULIE D BELL
Correspondent
Interventional Therapeutics Corp.
385 Oyster Pt. Blvd., Suite #6
South San Francisco,  CA  94080
Correspondent Contact JULIE D BELL
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/16/1990
Decision Date 08/08/1990
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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