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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Thermodilution
510(k) Number K811411
Device Name SWAN-GANZ HEPARIN COATED, ETC. CATHETER
Applicant
American Edwards Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Edwards Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.1915
Classification Product Code
KRB  
Date Received05/19/1981
Decision Date 06/12/1981
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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