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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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510(K)
Number
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Decision
Date
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immulite 2000 pap, models l2kpa2, l2kpa6 DIAGNOSTIC PRODUCTS CORP. k000257 02/23/2000
cortek uretheroscope CORTEK ENDOSCOPY, INC. k000200 03/03/2000
single size tendon spacer MEDIST INTERNATIONAL k000019 03/29/2000
screeners cocaine test; drugscreen dip cocaine test DRUG DETECTION DEVICES, LTD. k000350 04/11/2000
vapr 2.3mm wedge electrode for use with vapr system MITEK PRODUCTS k000936 04/19/2000
mityview 4-way lateral expander speculum PRISM ENTERPRISES, INC. k000444 04/21/2000
medvizer pacs, model release 2000 VITEL NET k000557 04/24/2000
jetlite 4000 J. MORITA USA, INC. k000078 05/15/2000
disposable pvc synthetic exam gloves, powder free SHANGHAI PM PLASTICS ENT. CO., LTD. k001432 07/05/2000
opi band ORTHOMERICA PRODUCTS, INC. k001167 07/07/2000

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