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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K893411
Device Name STEALTH DILATION CATHETER SYSTEM
Applicant
Target Therapeutics
130 Rio Robles
P.O. Box 610458
San Jose,  CA  95134
Applicant Contact MARIE DANIELS
Correspondent
Target Therapeutics
130 Rio Robles
P.O. Box 610458
San Jose,  CA  95134
Correspondent Contact MARIE DANIELS
Regulation Number870.1250
Classification Product Code
LIT  
Date Received05/02/1989
Decision Date 09/05/1989
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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