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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|---|---|---|---|
| plexur m | Osteotech, Inc. | k073405 |
03/03/2008 |
| 4.5mm locking broad & narrow compression plates, 4.5mm & 5.5mm cortical & cancellous locking screws, respectively. | DePuy Orthopaedics, Inc. | k072423 |
11/07/2007 |
| clearvision nuclear medicine imaging system | Gvi Technology Partners | k072191 |
10/25/2007 |
| diamondback 360 degree orbital atherectomy system | Cardiovascular Systems, Inc. | k072800 |
10/25/2007 |
| sentec digital monitoring system | Sentec AG | k071672 |
09/12/2007 |
| ascension humeral resurfacing arthoplasty (hra) system tps/ha | Ascension Orthopedics, Inc. | k071064 |
06/22/2007 |
| infinity delta/delta xl/ kappa/ gamma x xl/ vista xl/ sc7000/sc8000/ sc9000xl | Draeger Medical Systems, Inc. | k070566 |
06/04/2007 |
| vapotherm model# 2000i and 2000h | Vapotherm, Inc. | k070056 |
04/13/2007 |
| dimension vista (tm) bhcg flex(r) reagent cartridge, and bhcg calibrator, model# k6430,kc632 | Dade Behring, Inc. | k063754 |
02/23/2007 |
| cranex novus | Soredex Palodex Group OY | k063459 |
12/26/2006 |
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