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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K990331
Device Name SURGEN VALVE
Applicant
TIVA MEDICAL
2157 VISTA LA NISA
CARLSBAD,  CA  92009
Applicant Contact JIM CAPUTO
Correspondent
TIVA MEDICAL
2157 VISTA LA NISA
CARLSBAD,  CA  92009
Correspondent Contact JIM CAPUTO
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/02/1999
Decision Date 05/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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