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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|---|---|---|---|
| axon systems subdermal needle electrodes | AXON SYSTEMS, INC. | k050194 |
04/26/2005 |
| bioscrew xtralok, 8x35mm & 8x40mm violet | LINVATEC CORP. | k050497 |
03/25/2005 |
| oxycodone enzyme immunoassay and oxycodone calibrators and controls | Lin-Zhi International, Inc. | k050733 |
06/13/2005 |
| ge viewpoint | GENERAL ELECTRIC CO. | k050943 |
05/23/2005 |
| the philips mp20, mp30, mp40, mp50, mp60, mp70, mp80 and mp90 intellivue patient monitors | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH | k051106 |
07/01/2005 |
| bd phoenix automated microbiology system - ceftriaxone (strep) 0.0625 - 4ug/ml | BECTON, DICKINSON & CO. | k051138 |
06/03/2005 |
| powder-free blue nitrile examination gloves (tested for use with chemotherapy drugs) | MEDLINE | k051378 |
08/03/2005 |
| uropass ureteral access sheath, model 61224 | ACMI CORPORATION | k051593 |
09/02/2005 |
| nitrile powdered examination gloves (blue) | HARTALEGA SDN BHD | k051778 |
07/26/2005 |
| miot plating system | ORTHOFIX SRL | k051945 |
09/06/2005 |
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