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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 K810730
Device Name MODEL SP5107 THERMODILUTION CATHETER
Applicant
Gould, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Applicant Contact none none
Correspondent
Gould, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent Contact none none
Regulation Number870.1915
Classification Product Code
KRB  
Date Received03/17/1981
Decision Date 03/27/1981
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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