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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|---|---|---|---|
| opteform, osteofil, rti allograft paste ic, rti allograft strip ic | Regeneration Technologies, Inc. | k043421 |
02/16/2005 |
| bodyguard infusion pump system | Caesarea Medical Electronics , Ltd. | k042696 |
03/11/2005 |
| zodiac spinal fixation system | Alphatec/Nexmed | k050830 |
06/22/2005 |
| nobelreplace adapter, model 32412 | Nobel Biocare Uas, Inc. | k050444 |
07/07/2005 |
| silverseal orthotic component with x-static | Noble Fiber Technologies, Inc. | k051256 |
07/21/2005 |
| hemoglide series and hemoglide star series xk long-term hemodialysis catheters | C.R. Bard, Inc. | k051748 |
08/12/2005 |
| tem 3000 head coil | Mr Instruments, Inc. | k052200 |
08/19/2005 |
| du857 dual frequency ultrasound therapy and muscle stimulator system | Alfa Tech Medical Systems, Ltd. | k052340 |
12/09/2005 |
| rossmax non-invasive blood pressure monitors, models s380, k350 | Rossmax International , Ltd. | k052727 |
12/16/2005 |
| commander iii non-invasive blood pressure system | Cardiocom, LLC | k053304 |
12/30/2005 |
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