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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 K832287
Device Name NOVA BALLOON THERMODILUTION INFUSION
Applicant
NOVA MEDICAL SPECIALTIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
NOVA MEDICAL SPECIALTIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1240
Classification Product Code
DYG  
Date Received07/13/1983
Decision Date 10/19/1983
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
Recalls CDRH Recalls
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