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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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raven protest - steam RAVEN BIOLOGICAL LABORATORIES, INC. k041386 08/09/2004
acuson cv70 cardiovascular system SIEMENS MEDICAL SOLUTIONS USA, INC. k042044 08/13/2004
pediatric energy reducer, models aed-10 and aed-20 WELCH ALLYN, INC. k040479 09/14/2004
modification to synthes cranial plates SYNTHES (USA) k042987 11/23/2004
confluent surgical dual liquid applicator, model 70-2005093 CONFLUENT SURGICAL,INC k042588 12/09/2004
churchill medical dual chamber empty container CHURCHILL MEDICAL SYSTEMS, INC. k041038 12/21/2004
willi geller creation zi porcelain JENSEN INDUSTRIES, INC. k043201 01/11/2005
mosaic non-modular proximal body and eas offset modular humeral head BIOMET MANUFACTURING CORP. k042321 01/28/2005
shineball pvc manual resusciator, ent-1001, ent-1003, ent-1005, shineball silicone manual resusciator, ent-1022, ENTER MEDICAL CORPORATION k042556 03/11/2005
models fac-63 and fac-127 foot and ankle coils MRI DEVICES CORPORATION k050514 03/25/2005

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