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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 K840824
Device Name HEPARIN COATED THERMODILUTION CATHETERS
Applicant
Gould, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact none none
Correspondent
Gould, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact none none
Regulation Number870.1915
Classification Product Code
KRB  
Date Received02/24/1984
Decision Date 05/23/1984
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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