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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K900379
Device Name HYCULT DIAMOND CORONARY BYPASS KNIFE
Applicant
St. Jude Medical, Inc.
One Lillehei Plaza
St. Paul,  MN  55117
Applicant Contact WILLIAM F JACKSON
Correspondent
St. Jude Medical, Inc.
One Lillehei Plaza
St. Paul,  MN  55117
Correspondent Contact WILLIAM F JACKSON
Regulation Number870.4500
Classification Product Code
DWS  
Date Received01/26/1990
Decision Date 03/19/1990
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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