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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K860526
Device Name NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH
Applicant
Nova Medical Specialties
449 Oakshade Rd.
Indian Mills,  NJ  08088
Applicant Contact JOSEPH C GRIFFIN
Correspondent
Nova Medical Specialties
449 Oakshade Rd.
Indian Mills,  NJ  08088
Correspondent Contact JOSEPH C GRIFFIN
Regulation Number870.2870
Classification Product Code
DXO  
Date Received02/11/1986
Decision Date 05/02/1986
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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