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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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sigma diagnostics sigma-cal, model s2936 SIGMA DIAGNOSTICS, INC. k010652 03/30/2001
at home drug test, model 9068 t PHAMATECH k010653 04/05/2001
at home drug test, model 9078 t PHAMATECH k010654 04/05/2001
at home drug testt, model 9150 t PHAMATECH k010655 04/05/2001
copeland mb resurfacing humeral heads BIOMET MANUFACTURING, INC. k010657 09/14/2001
modified uss fracture system SYNTHES (USA) k010658 06/04/2001
sea-long medical treatment hood SEA-LONG MEDICAL SYSTEMS, INC. k010659 05/16/2001
modification to tissuelink bipolar forceps TISSUELINK MEDICAL, INC. k010661 05/03/2001
modification to tissuelink monopolar floating ball TISSUELINK MEDICAL, INC. k010662 04/27/2001
powdered synthetic vinyl patient exam glove TONG RUHN MEDICAL PRODUCTS CO., LTD. k010663 03/30/2001

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