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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K844598
Device Name LARIAT CATHETER
Applicant
Mallinckrodt Critical Care
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Applicant Contact THOMAS W TUSING
Correspondent
Mallinckrodt Critical Care
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Correspondent Contact THOMAS W TUSING
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/26/1984
Decision Date 02/01/1985
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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