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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
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510(K)
Number
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Decision
Date
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gradia GC AMERICA, INC. k001518 07/05/2000
unicorn model sys0630 DANISH DIAGNOSTIC DEVELOPMENT A/S k001888 06/30/2000
electrosurgical electrode family, model 20-2 needle balloon catheter, model 40-4 needle balloon catheter, model 60-6 nee NOVASYS MEDICAL, INC. k001150 06/29/2000
fastpack psa immunoassay, fastpack system QUALISYS DIAGNOSTICS, INC. k994419 06/28/2000
scandinavian ivf sciences ab, g2.2 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB k000619 06/27/2000
electrosurgical electrode family NOVASYS MEDICAL, INC. k001151 06/27/2000
monarch ii iol delivery system ALCON RESEARCH, LTD. k001157 06/27/2000
temporary pacemaker extension cable, models 5235, 5235a, 5235v, temporary pacemaker surgical extension cable, models 528 PACE MEDICAL k001180 06/27/2000
shimadzu mobile x-ray system mux-100 series SHIMADZU CORP. k001517 06/27/2000
infinity amylase reagent (procedure no. 580/568) SIGMA DIAGNOSTICS, INC. k001569 06/26/2000

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