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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 K864818
Device Name ACKRAD TDI SET
Applicant
Ackrad Laboratories
70 Jackson Dr.
Cranford,  NJ  07016
Applicant Contact BERNARD ACKERMAN
Correspondent
Ackrad Laboratories
70 Jackson Dr.
Cranford,  NJ  07016
Correspondent Contact BERNARD ACKERMAN
Regulation Number870.1915
Classification Product Code
KRB  
Date Received12/09/1986
Decision Date 04/09/1987
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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