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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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rigid gas permeable contact lens POLYMER TECHNOLOGY k001960 08/28/2000
rossmax medipro, models 100f, 200f, and 300f blood pressure monitors ROSSMAX INTERNATIONAL LTD. k013539 01/17/2002
royal imperial powdered latex examination gloves with protein content labeling claim (200 micrograms or less) KOON SENG SDN.BHD k013537 12/07/2001
rusch bronchus blocker kit RUSCH INTL. k010596 11/21/2001
rx everest JENERIC/PENTRON, INC. k001051 04/28/2000
rx viatrac 14 peripheral dilatation catheter, otw viatrac 18 peripheral dilatation catheter, rx herculink 14 biliary stn VASCULAR INTERVENTION k011464 06/13/2001
s45 (ocufilcon a) spherical, aspherical, toric and multifocal soft contact lens for daily wear (clear and tinted, fully- BESCON CO., LTD. k001962 07/09/2001
safari RANGER ALL SEASON CORP. k010606 03/16/2001
safe-point vac, safe-point m-d blood collection systems NORTH AMERICAN MEDICAL PRODUCTS, INC. k001965 02/02/2001
salute ONUX MEDICAL, INC. k003522 02/13/2001

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