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U.S. Department of Health and Human Services

510(K) Premarket Notification

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card guard personal electrocardiogram transmitter, model cg-6206/6306 CARD GUARD SCIENTIFIC SURVIVAL, LTD. k000225 02/11/2000
single size tendon spacer MEDIST INTERNATIONAL k000019 03/29/2000
agilent information center software for m3150a and m3153a and agilent m2/m3/m4 compact portable patient monitor AGILENT TECHNOLOGIES, INC. k001057 05/03/2000
ers radial head replacement DEPUY ORTHOPAEDICS, INC. k000658 05/11/2000
'cottony' ii dacron, silky ii polydek & tevdek ii polyester nonabsorbable surgical suture GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) k001434 06/12/2000
bojrab universal long imlant, model tbd GYRUS ENT L.L.C. k001902 07/10/2000
mdi gliadin g test MICRO DETECT, INC. k002359 10/19/2000
ace aim ttc fusion nail DEPUY ORTHOPAEDICS, INC. k003797 12/15/2000
trinity polyaxial screw, mehdian spinal rod (6mm), model 159.xxx series catalogue numbers CORIN U.S.A. k010776 04/06/2001
vega ultrasonic nebulizer VEGA TECHNOLOGIES, INC. k002831 05/23/2001

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