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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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invigra male latex condom blue colored and vanilla flavored INDUS MEDICARE LTD. k000040 03/21/2000
biocellect -perio IMTEC CORP. k020396 04/10/2002
implantech composite facial implants (malar, chin, and nasal) IMPLANTECH ASSOCIATES, INC. k002886 11/24/2000
igel 55uv (methafilcon a) soft (hydrophilic) contact lens for daily wear,igel 55 uv multifocal (methafilcon a) soft IGEL VISION CARE PTE LTD. k020855 06/04/2002
ics medical model vg-30 video goggles ICS MEDICAL k013060 12/10/2001
nlite system,model a00-1025 ICN PHOTONICS LTD. k013461 01/17/2002
i-stat prothrombin time test I-STAT CORPORATION k020355 05/14/2002
i-flow elastomeric pump I-FLOW CORP. k020862 03/26/2002
gamow bag, hyper oxy, hyper oxy p/t, pressure-cizer HYPERBARIC TECHNOLOGIES, INC. k001409 08/02/2000
hydrofera bacteriostatic wound dressing HYDROFERA, LLC. k013462 01/11/2002

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