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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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510(K)
Number
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Decision
Date
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contour labral nail, model 533520a Bionx Implants, Inc. k003970 01/12/2001
contact lens inserter/remover Optimum Manufacturers, Inc. k841163 06/01/1984
compression hip screw system Pfizer, Inc. k850886 04/19/1985
commview system A T & T Technologies, Inc. k862715 10/16/1986
comfort latex powdered patient examination gloves with protein label claim contains 200 micrograms or less of total wate Comfort Rubber Gloves Industries Sdn. Bhd. k001042 05/23/2000
combison 301 pw ultrasound system and transducers Medison Co., Ltd. k002491 08/25/2000
coalescent u-clip delivery and disposal device Coalescent Surgical k003958 02/06/2001
cm 5000 monitor airway pressure Canadian Monaghan , Ltd. k871083 04/08/1987
clirans te12 hollow fiber dialyzer Terumo Medical Corp. k812498 09/29/1981
clickzip needle retractable safety syringe Medical Device Manufacturer (Thailand) , Ltd. k051694 12/21/2005

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