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U.S. Department of Health and Human Services

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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keeler wide angle ophthalmoscope model 1130-p-5004 KEELER INSTRUMENTS, INC. k032087 11/26/2003
h/s catheter set CATHETER RESEARCH, INC. k032835 12/11/2003
profeel powder free, ploymer coated polyisoprene surgical gloves, sterile WRP ASIA PACIFIC SDN. BHD. k032942 12/17/2003
hemaderm MEDAFOR, INC. k033666 12/17/2003
compress distal femoral replacement BIOMET, INC. k031804 12/18/2003
shiraz-anterior system SPINE NEXT AMERICA k033965 03/04/2004
polymer coated, powder-free latex examination gloves with protein labeling (less than 50 ug/g per glove) SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. k040408 03/17/2004
quixx posterior restorative DENTSPLY INTERNATIONAL k040144 04/01/2004
mydon c WAVELIGHT LASER TECHNOLOGIE AG k040384 05/14/2004
swift anterior cervical plate system DEPUY SPINE,INC k040655 06/02/2004

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