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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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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 rad PRONOSCO A/S k002500 10/23/2000
tampax satin tampons, closed end flushable applicator; tampax tampons, open end flushable applicator PROCTER & GAMBLE CO. k002096 09/08/2000
mityview 4-way lateral expander speculum PRISM ENTERPRISES, INC. k000444 04/21/2000
aquanet, model ec 2000 PRIME PACIFIC HEALTH INNOVATIONS CORPORATION k000031 09/10/2001
premier ultrasonic scaler and inserts PREMIER DENTAL PRODUCTS CO. k010195 04/17/2001
medpor quad motility implant POREX SURGICAL, INC. k010902 06/19/2001
umbicut POLLAK (INTL.), LTD. k000227 04/27/2000
tc-plus solution knee PLUS ORTHOPEDICS k000666 10/13/2000
dixi 2 PLANMECA OY k000428 04/28/2000

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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