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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K900460
Device Name MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER
Applicant
Novoste Corp.
P.O.Box 5149
Montana Industrial Park
Aguadilla,  PR  00605
Applicant Contact CHARLES LARSEN
Correspondent
Novoste Corp.
P.O.Box 5149
Montana Industrial Park
Aguadilla,  PR  00605
Correspondent Contact CHARLES LARSEN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received01/30/1990
Decision Date 07/17/1990
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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