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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K812563
Device Name SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
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 Number870.1240
Classification Product Code
DYG  
Date Received09/08/1981
Decision Date 09/25/1981
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
Recalls CDRH Recalls
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