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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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polygram 98 anorectal function testing application, model 9043s0111 MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S k000386 05/05/2000
yoshida wave pict cam intraoral camera, sigma biomedics sigmacam intraoral camera THE YOSHIDA DENTAL MFG. CO., LTD. k000577 05/05/2000
serim leukocyte esterase test strips SERIM RESEARCH CORP. k000578 05/05/2000
modification to mixject dispensing pin/with detachable vial holder/with detachable vial holder and pre-attached needle MEDIMOP MEDICAL PROJECTS, LTD. k001293 05/05/2000
vitros chemistry products crea slide, virtros chemistry products calibrator kit 1 Ortho-Clinical Diagnostics, Inc. k001310 05/05/2000
connect data management system ABBOTT DIABETES CARE INC. k994433 05/05/2000
eyecap imaging system CLEMENT CLARKE INTL., LTD. k000368 05/04/2000
shuttle stop ISOTIS NV k000587 05/04/2000
direct tibc calibrator REFERENCE DIAGNOSTICS, INC. k000783 05/04/2000
kavo k.e.y. laser 1242 KAVO AMERICA k000805 05/04/2000

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