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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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polymer coated, powder-free latex examination glove contains 50 micrograms or less of total water extractable protein pe KOSSAN LATEX INDUSTRIES (M) SDN. BHD. k001190 05/23/2000
self adhering navigus guide IMAGE-GUIDED NEUROLOGICS, INC. k001192 06/07/2000
sterichek total chlorine reagent strips ENVIRONMENTAL TEST SYSTEMS, INC. k001194 07/11/2000
jel bios 90 (code name rd-2401) J.F. JELENKO & CO., INC. k001196 05/11/2000
cocaine metabolite intercept micro-plate eia ORASURE TECHNOLOGIES, INC. k001197 05/11/2000
datascope nitinol catheter guide wire (145 cm), datascope nitinol catheter guide wire (175 cm), datascope nitinol cathet DATASCOPE CORP. k001198 05/12/2000
multix compact k and multix l radiographic x-ray systems SIEMENS MEDICAL SOLUTIONS USA, INC. k001201 06/01/2000
olympus um 2r/3r ultrasonic probe and associated ancillary equipment for female reproductive tract THE OLYMPUS OPTICAL CO. k001203 05/26/2000
espirt RESPIRONICS, INC. k001208 05/12/2000
insight plus 9000 phased array torso and pelvis coil USA INSTRUMENTS, INC. k001209 06/01/2000

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