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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 K760533
Device Name CATHETER, FLOW DIRECTED THERMAL DILUTION
Applicant
GOULD, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GOULD, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1240
Classification Product Code
DYG  
Date Received08/30/1976
Decision Date 09/09/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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