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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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magic mobility 4 x 4 wheelchair VESTIL MANUFACTURING CORP. k000796 08/11/2000
venusa, ltd. extension set with filter VENUSA LTD. k994429 03/03/2000
rx viatrac 14 peripheral dilatation catheter, otw viatrac 18 peripheral dilatation catheter, rx herculink 14 biliary stn VASCULAR INTERVENTION k011464 06/13/2001
e7512 premie rem polyhesive ii patient return electrode VALLEYLAB, INC. k994428 03/07/2000
magna 5000 phased array ctl spine coil USA INSTRUMENTS, INC. k000002 02/23/2000
interventional body coil USA INSTRUMENTS, INC. k000437 04/14/2000
magna 5000 phased array ctl spine coil USA INSTRUMENTS, INC. k994345 02/14/2000
spiral radius rodding system UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC k000009 03/10/2000
monofilament biosyn suture UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC k000037 03/30/2000
ultratemp temporary polycarboxylate cement ULTRADENT PRODUCTS, INC. k994261 02/02/2000

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