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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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orthopantomograph op200, op200d, and orthoceph oc200, oc200d INSTRUMENTARIUM CORP. IMAGING DIVISION k043612 02/09/2005
oxytec, model 900 OXYTEC MEDICAL CORPORATION k043615 02/09/2005
potassium test kit and electrolyte cal 1 and 2 RANDOX LABORATORIES, LTD. k043267 02/10/2005
easyspine system LDR SPINE USA k043094 02/11/2005
devilbiss autoadjust, model 9054 series SUNRISE MEDICAL k043282 02/11/2005
e-z frame external surgical support boot SIGNAL MEDICAL CORP. k043289 02/11/2005
envitec reusable multi-site y spo2 sensors ENVITEC-WISMAR GMBH k043463 02/11/2005
stealth products seating system STEALTH PRODUCTS k050264 02/11/2005
calforma calcium sulfate bone graft barrier, model 0.5g/1.0g LIFECORE BIOMEDICAL k042730 02/14/2005
n antisera to human immunoglobulins (igg, iga and igm) DADE BEHRING, INC. k042735 02/15/2005

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