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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 K881893
Device Name NUMED BALLOON THERMODILUTION CATHETER
Applicant
NuMED, Inc.
Main St.
Hopkinton,  NY  12940
Applicant Contact ALLEN J TOWER
Correspondent
NuMED, Inc.
Main St.
Hopkinton,  NY  12940
Correspondent Contact ALLEN J TOWER
Regulation Number870.1915
Classification Product Code
KRB  
Date Received05/05/1988
Decision Date 09/06/1988
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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