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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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modification of nc-stat NEUROMETRIX, INC. k013459 01/17/2002
swift low profile cup (pro cup) SWIFT DELIVERY PRODUCTS k013460 01/17/2002
nlite system,model a00-1025 ICN PHOTONICS LTD. k013461 01/17/2002
toco lite, model td-01 VENTREX, INC. k013477 01/17/2002
microlife upper arm automatic blood pressure monitor, model bp-3bto-1, with optional thermal printer, model pr 1ka1 MICROLIFE CORP. k013485 01/17/2002
smith & nephew operative hysteroscope, model 7209208; smith & nephew continuous flow sheath, model 8105224 SMITH & NEPHEW, INC. k013870 01/17/2002
konica laser imager, drypro model 751/752 KONICA MINOLTA MEDICAL & GRAPHIC, INC. k013052 01/16/2002
synchron systems pancreatic amylase (pam) reagent BECKMAN COULTER, INC. k013978 01/15/2002
incare advance; intermittent catheter, plus intermittent catheter, plus kit HOLLISTER, INC. k013483 01/14/2002
hydrofera bacteriostatic wound dressing HYDROFERA, LLC. k013462 01/11/2002

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