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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
Date
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sentec digital monitor model #sdm SENTEC INC. k041548 08/09/2004
progeny mpse intraoral dental x-ray sensor PROGENY, INC. k041831 08/09/2004
durasul bipolar CENTERPULSE ORTHOPEDICS, INC. k040947 08/27/2004
fabius gs anesthesia system; fabius tiro anesthesia system DRAEGER MEDICAL, INC. k042086 08/31/2004
shinmed mode sw-988 untrasonic nebulizer SHINING WORLD HEALTH CARE CO., LTD. k031370 09/01/2004
baxter duplotip surgical sealant applicator MICROMEDICS, INC. k033589 10/04/2004
gdc-10 360 degree coil sr; gdc-10 360 degree soft coil sr; gdc-18 360 degree coil BOSTON SCIENTIFIC CORP. k042539 10/19/2004
ossaplast ortho, o.5ml, model# 221 900, ossaplast ortho, 1.0ml, model# 221 901, ossaplast ortho, 3.0ml, model# 221 903 OSSACUR AG k042305 10/21/2004
modification to silhouette ic or silhouette; laser-lok surface treatment -optional surface modification to implants BIO-LOK INTL., INC. k041136 10/22/2004
vertex reconstruction system MEDTRONIC SOFAMOR DANEK k042789 12/21/2004

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