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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
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spirit iii totalsense cardiac coil USA INSTRUMENTS, INC. k024187 02/04/2003
evergreen non-sterile powdered natural or colored latex examination glove YTY INDUSTRY (MANJUNG) SDN. BHD. k024355 02/03/2003
thermacool tc system THERMAGE, INC. k030142 02/03/2003
modification to pentra 60 and pentra 60c+ ABX DIAGNOSTICS k030144 01/31/2003
modification to animec, models am-2s-4, am-2s-5, lt-1-4 & lt-1-5 ELLTEC CO., LTD. k024373 01/28/2003
disposble powder free vinyl synthetic exam gloves with aloe vera, green color SAFEHEALTH MEDICAL SUPPLY CORP. k024081 01/28/2003
linical protein 5 calibration verifiers levels a-e for beckman coulter array and immage protein systems CLINIQA CORPORATION k030150 01/28/2003
smith & nephew global bipolar system SMITH & NEPHEW, INC. k023743 01/23/2003
acuvue 2 colours brand (etafilcon a) soft (hydrophilic) contact lens with uv blocker JOHNSON & JOHNSON VISION CARE, INC. k024177 01/22/2003
coalescent surgical u-clip and accessories COALESCENT SURGICAL k024366 01/17/2003

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