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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 K852914
Device Name ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION
Applicant
Norton Performance Plastics Corp.
P.O. Box 3660
Akron,  OH  44309
Applicant Contact ROGERS MOGILL
Correspondent
Norton Performance Plastics Corp.
P.O. Box 3660
Akron,  OH  44309
Correspondent Contact ROGERS MOGILL
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/10/1985
Decision Date 09/25/1985
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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