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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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Decision
Date
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prn thermalcare, model 3000 AMERICAN HEALTHCARE PRODUCTS, INC. k062794 12/07/2006
the trufill dcs detachable coil system; the trufill dcs orbit detachable coil system CORDIS NEUROVASCULAR, INC. k063254 12/07/2006
luxvision slit lamp U.S. OPHTHALMIC LLC k063416 12/07/2006
humidcare heated humidifier, model 9s-004 APEX MEDICAL CORP. k062664 12/06/2006
repair kit for xpresso, decathlon, and alta lr catheters SPIRE BIOMEDICAL, INC. k062435 12/05/2006
ez-mio, ez-io distal tibia VIDACARE CORPORATION k062956 12/05/2006
demetron a.2 SYBRON DENTAL SPECIALTIES k063116 12/05/2006
modification to vsm- vital signs monitor, (vsm 300 ) WELCH ALLYN PROTOCOL, INC. k063419 12/04/2006
illumimed PHOTOACTIF, LLC k060792 12/01/2006
cook endoscopy esophageal dilation balloon COOK ENDOSCOPY k061937 12/01/2006

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