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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
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sterile latex surgical gloves (powdered) with protein content labeling claim (100 micrograms or less) SMART GLOVE CORP. SDN BHD k011066 09/11/2001
sterile piston syringe ABBOTT LABORATORIES k002717 01/08/2001
sterile powdered latex surgeon gloves SUPERMAX GLOVE MANUFACTURING SDN BHD k010198 02/23/2001
steritec autoclave tapes, model ci122 & ci1234 STERITEC PRODUCTS, INC. k001649 06/23/2000
stryker navigation system - ent module STRYKER CORP. k002732 10/02/2000
summit cemented hip prosthesis DEPUY ORTHOPAEDICS, INC. k013352 12/17/2001
summit occipito-cervico-thoracic (oct) spinal system DEPUY ACROMED k002733 12/15/2000
super nova, acubeam LIGHT FORCE THERAPY, INC. k001179 10/27/2000
surgical contra-angel handpieces types ws-56e,ws-75e/km,ws-92 e/3,surgical straight handpieces types, s-9, s-10, s-11 W & H DENTALWERK BUERMOOS GMBH k011061 06/28/2001
swabsite swabbable valve, model 245000 QUEST MEDICAL, INC. k002689 03/06/2001

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