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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
Date
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v/x aspheric toric multifocal (polymacon) soft (hydrophilic) lenses with a clear or blue visibility tint JOE B. GOLDBERG, O.D. k003042 01/22/2001
urological catheter APOGEE, INC. k992137 09/03/1999
urethane picc line model upics- COOK, INC. k992198 08/27/1999
uniport self-contained portable dental unit ARROW INDUSTRIES LLC k040117 04/21/2004
unicem 3M ESPE DENTAL PRODUCTS k062292 10/25/2006
unicel dxc 600 and 800 synchron systems BECKMAN COULTER, INC. k042291 11/12/2004
ultracision harmonic scalpel coagulating shears, model lcsc5,lcsc1,cs23c,cs231,cs14c,cs141,lcsb5,lcsk5,lcs15,lcs16,cs150 ETHICON ENDO-SURGERY, INC. k002981 04/09/2001
truly automatic blood pressure monitor, model db11 TRULY INSTRUMENT LIMITED k081852 12/12/2008
tru-touch pf vinyl powder free examination glove MAXXIM MEDICAL k992122 07/15/1999
trophypan TROPHY RADIOLOGIE k023346 01/03/2003

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