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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K900034
Device Name ANGIO-MAX
Applicant
Accumed Systems, Inc.
14515 Drexmore Rd.
Shaker Heights,  OH  44120
Applicant Contact PETER PETRUS
Correspondent
Accumed Systems, Inc.
14515 Drexmore Rd.
Shaker Heights,  OH  44120
Correspondent Contact PETER PETRUS
Regulation Number870.1650
Classification Product Code
DXT  
Date Received01/02/1990
Decision Date 05/22/1990
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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