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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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single size tendon spacer Medist International k000019 03/29/2000
card guard personal electrocardiogram transmitter, model cg-6206/6306 Card Guard Scientific Survival , Ltd. k000225 02/11/2000
enzyme immunoassay anti-centromere antibody test Helix Diagnostics, Inc. k000489 04/05/2000
access ck-mb on the access immunoassay analyzer Beckman Coulter, Inc. k000716 03/20/2000
multisafe powder-free patient latex examination gloves with protein content labeling claim (50 micrograms or less) Multisafe Sdn. Bhd. k000999 05/22/2000
eagle endo specimen retrieval bag Eagle Endoscopic, Inc. k001264 05/30/2000
scipro(tm) flexible stone dislodger and retrieval set Scion Cardiovascular, Inc. k001563 11/22/2000
kontur 55 soft lens Kontur Kontact Lens Co., Inc. k001908 08/18/2000
rd-2104 J.F. Jelenko & Co., Inc. k002222 08/31/2000
periform perineometric probe, model 8300 Neen Design , Ltd. k002617 04/05/2001

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