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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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vaginal applicator shielded MICK RADIO-NUCLEAR INSTRUMENTS, INC. k001544 11/17/2000
invac DUNCAN HYND ASSOCIATES, LTD. k002608 11/16/2000
newgen system STRYKER INSTRUMENTS k002619 11/16/2000
suresmile system ORA METRIX, INC. k002620 11/16/2000
litwin cruicate anchor INSTRUMENT MAKAR, INC. k002600 11/15/2000
vbmax A-M SYSTEMS, INC. k000654 11/14/2000
pp-cap eia for the detection of iga antibodies to h. pylori ENTERIC PRODUCTS, INC. k001177 11/13/2000
surgical system with cryoguide ENDOCARE, INC. k002615 11/13/2000
friendly light er:yag pulsed laser INNOTECH USA, INC. k000023 11/06/2000
conchatherm 2000 humidification system, models 500-00, -10, -20, -30, -40, -50, & -60 HUDSON RESPIRATORY CARE, INC. k001213 11/03/2000

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