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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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rusch floneil; flocath introgel RUSCH INTL. k020714 07/01/2002
rossmax automatic wristwatch blood pressure monitor, model bpw138 ROSSMAX INTERNATIONAL LTD. k011523 06/14/2001
roche acetaminophen ROCHE DIAGNOSTICS CORP. k013757 01/08/2002
rigid gas permeable contact lens BAUSCH & LOMB INCORPORATED k013762 04/03/2002
reveal plus insertable loop recorder system model 9526 implantable recorder and model 6191 patient activator MEDTRONIC VASCULAR k011098 05/04/2001
restore-x FIRST SCIENTIFIC LIMITED k011520 07/23/2001
resorbable screw anchor ARTHROTEK, INC. k012872 11/20/2001
resorbable bone pins BIOMET, INC. k011522 07/31/2001
renax hemodialysis blood tubing set; sunder hemodialysis blood tubing set SUNDER BIOMEDICAL TECH. CO., LTD. k014140 11/18/2002
reliefband nst device, model wb-2l, wb-6l, wb-rl WOODSIDE BIOMEDICAL, INC. k994387 03/16/2000

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