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U.S. Department of Health and Human Services

510(K) Premarket Notification
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141 to 150 of 500 Results *
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510(K)
Number
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Decision
Date
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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
sansibar cpap system PRYM MEDICAL LTD. k000888 08/15/2000
eva -vacuum assist device for clitoral therapy PROSURG, INC. k001576 12/28/2000
aquanet, model ec 2000 PRIME PACIFIC HEALTH INNOVATIONS CORPORATION k000031 09/10/2001
render-plan 3-d 4.00 & precise-plan 1.0 PRECISION THERAPY INTL., INC. k002240 08/23/2000
umbicut POLLAK (INTL.), LTD. k000227 04/27/2000
seragard vascular access patch PLATINUM SERVICES, INC. k001175 09/18/2000

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