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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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biopatch antimicrobial dressing INTEGRA LIFESCIENCES CORP. k003229 10/26/2001
v score with auto gate model tbd VITAL IMAGES, INC. k003230 12/27/2000
hms neuromuscular stimulator, model hms 3 HOME MEDICAL SERVICES k003231 01/12/2001
rs nitrilstat medical examination gloves, powder free (non-sterile) RIVERSTONE RESOURCES SDN. BHD. k003232 10/26/2000
rs nitrilstst medical examination gloves, powdered (non sterile) blue RIVERSTONE RESOURCES SDN. BHD. k003233 11/03/2000
pe.r.i. ii knee fracture system DEPUY ORTHOPAEDICS, INC. k003235 11/06/2000
retinadx REGULATORY ASSOCIATES, INC. k003236 11/02/2000
u2 hip stem, ti porous coated UNITED ORTHOPEDIC CORP. k003237 01/10/2001
solid state x-ray imaging devices CARES BUILT, INC. k003238 10/01/2001
liquichek blood gas plus co-oximeter control (800 series), model504,505,506 BIO-RAD k003239 11/30/2000

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