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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ion-Exchange Chromatography
510(k) Number K890113
Device Name THE CDI(R) SYSTEM 400
Applicant
Cardiovascular Devices, Inc.
2801 Barranca
Irvine,  CA  92714
Applicant Contact STEVEN ARICK
Correspondent
Cardiovascular Devices, Inc.
2801 Barranca
Irvine,  CA  92714
Correspondent Contact STEVEN ARICK
Regulation Number862.2230
Classification Product Code
DJY  
Date Received01/11/1989
Decision Date 05/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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