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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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total cure BISCO, INC. k010196 04/05/2001
transamerica digital ems TRANSAMERICA MEDICAL SYSTEMS k010665 04/27/2001
tray adapters, multiple ARPLAY MEDICAL S.A. k010174 04/18/2001
treatvision VARIAN MEDICAL SYSTEMS, INC. k002194 08/18/2000
tri-fix spinal fixation system ENDIUS, INC. k000766 06/01/2000
trifix spinal fixation system ENDIUS, INC. k001627 06/03/2000
trochanteric reattachment device (standard) and (long), model 501-066, 501-067 PIONEER SURGICAL TECHNOLOGY k001709 08/31/2000
trojan extra large latex condom ARMKEL, LLC. k001212 05/09/2000
trojan latex condom with male genital desensitizer lubricant ARMKEL, LLC. k000748 04/06/2000
u2 hip stem, ti porous coated UNITED ORTHOPEDIC CORP. k003237 01/10/2001

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