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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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cryoplan system CRYOMEDICAL SCIENCES, INC. k011073 08/22/2001
cs/3 critical care monitor with s-icu99(a) DATEX-OHMEDA k000168 04/13/2000
ctc dvt-1 calf garment, model dvt-1 COMPRESSION THERAPY CONCEPTS, INC. k000147 04/13/2000
dardik carotid shunt VASCUTECH, INC. k001621 12/06/2000
datascope nitinol catheter guide wire (145 cm), datascope nitinol catheter guide wire (175 cm), datascope nitinol cathet DATASCOPE CORP. k001198 05/12/2000
datex-ohmeda tuffsat 3000 pulse oximeter DATEX-OHMEDA, INC. k001688 06/30/2000
defender room air cleaner, model rac-3000a HMI INDUSTRIES, INC. k002692 11/17/2000
delta 16 tact INSTRUMENTARIUM IMAGING, INC. k001171 05/12/2000
depuy contour unicompartmental knee prosthesis DEPUY ORTHOPAEDICS, INC. k000172 02/03/2000
dermaguard pf brown powder free latex surgical gloves; model style 38 ANSELL PERRY k002192 07/27/2000

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