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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|---|---|---|---|
| cardioblate gemini surgical ablation device, models 49260 and 49261 | MEDTRONIC VASCULAR | k070311 |
04/24/2007 |
| powdered natural rubber latex examination gloves (protein label claim) 200 micrograms or less of total water extractable | MEDTEXX MANUFACTURING SDN. BHD. | k070821 |
05/10/2007 |
| accu-chek performa system | ROCHE DIAGNOSTICS CORP. | k070585 |
05/25/2007 |
| integra selector ultrasonic surgical aspirator system with bone tip | INTEGRA RADIONICS, INC. | k071669 |
08/17/2007 |
| model 300d home oxygen liquefier | COPD PARTNERS, INC. | k071461 |
08/21/2007 |
| raphael color asv ventilator | HAMILTON MEDICAL AG | k071194 |
10/18/2007 |
| powder-free vinyl patient examination gloves | SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD | k073193 |
12/20/2007 |
| posterior cervicothoracic spinal fixation system (pcfs) | LANX, LLC | k071905 |
12/28/2007 |
| digiflo concentrator analyzer | DIGIFLO, INC. | k072469 |
01/03/2008 |
| innervue diagnostic scope system | BIOMET ORTHOPEDICS, INC. | k072879 |
01/14/2008 |
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