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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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at home drug test, model 9068 PHAMATECH k994233 12/30/1999
at home drug test, model 9083 PHAMATECH k994234 12/30/1999
at home drug test, model 9133 PHAMATECH k994236 12/30/1999
at home drug test, model 9063 PHAMATECH k994237 12/30/1999
disentronic penfine injection pen needle DISETRONIC MEDICAL SYSTEMS k994197 12/29/1999
geiger disposable electrosurgical electrode, model 435 GEIGER MEDICAL TECHNOLOGIES, INC. k994075 12/27/1999
modification to bio-logic evoked potential for abaer/ navigator pro. BIO-LOGIC SYSTEMS CORP. k994149 12/27/1999
gyrus endourology system: axipolar resectoscope electrode GYRUS MEDICAL LTD. k994166 12/27/1999
s.m.a.r.t. nitinol stent transhepatic biliary system CORDIS CORP. k994068 12/23/1999
modular reach hip BIOMET, INC. k994038 12/22/1999

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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