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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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510(K)
Number
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Decision
Date
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riza band stretcher (rbs)-60000 R-MED, INC. k001236 07/17/2000
acti-flex fluid delivery system or acti-flex f d s R-GROUP INTL. k001233 12/13/2000
fastpack psa immunoassay, fastpack system QUALISYS DIAGNOSTICS, INC. k994419 06/28/2000
powder free latex examination patient gloves PURNABINA SDN BHD k994420 09/18/2000
aeronox universal, model p/n 360000, aeronox bedside, model p/n 360001, aeronox transport transport, model p/n 360002 PULMONOX MEDICAL CORP. k000653 08/04/2000
glovetex, latex examination gloves, powdered non-sterile.(protein content labeling) PT. WRP BUANA MULTICORPORA k994426 05/23/2000
pst electrosurgical generator, model 2150, pst bipolar forceps, model ebf 1228 PST, INC. k003249 12/12/2000
powder-free latex examination gloves with protein label claim contains 50 micrograms or less of total water label claim PROTECTION GLOVES SDN. BHD. k000667 04/28/2000
powder-free non-vhlorinated polymer coated latex examination gloves contains 100 micrograms or less of total water extra PROTECTION GLOVES SDN. BHD. k000668 04/28/2000
x-posure system version 2 mammo PRONOSCO A/S k003656 12/15/2000

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