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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 K843411
Device Name THERMAL DILUTION CATHETER
Applicant
ANDOVER MEDICAL, INC.
23 BALLARD WAY
LAWRENCE,  MA  01843
Applicant Contact ROBERT TETU
Correspondent
ANDOVER MEDICAL, INC.
23 BALLARD WAY
LAWRENCE,  MA  01843
Correspondent Contact ROBERT TETU
Regulation Number870.1240
Classification Product Code
DYG  
Date Received08/31/1984
Decision Date 10/18/1984
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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