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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
Sort by PMA Number [0-9]
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510(K)
Number
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Decision
Date
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human serum albumin (hsa) INVITROCARE, INC. k000940 05/04/2000
multi-pulse 2000 IMAGING SCIENCES INTL., INC. k001248 05/04/2000
multi lumen suction syringe spray dispenser BIOSURGICAL CORP. k000438 05/03/2000
au5, au6 BIOSOUND ESAOTE, INC. k000681 05/03/2000
4631 duo delivery system A-DEC, INC. k000966 05/03/2000
4635 assistant's instrumentation A-DEC, INC. k000967 05/03/2000
3181 duo delivery system A-DEC, INC. k000968 05/03/2000
lorenz titanium fracture / reconstruction plating system WALTER LORENZ SURGICAL, INC. k001238 05/03/2000
kronner low profile scope holder KRONNER PROTOTYPES, INC. k000663 05/02/2000
tfx medical safety needle with introducer TFX MEDICAL, INC. k000665 05/02/2000

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