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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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primaflow DMG USA, INC. k002086 08/17/2000
cooltouch ii NEW STAR LASERS, INC. k002347 08/17/2000
neuro scan medical systems a4000 NEURO SCAN LABS k001562 08/16/2000
linkmax GC AMERICA, INC. k001823 08/16/2000
neolus needle TERUMO EUROPE N.V. k001572 08/14/2000
pain care 2000l BREG, INC. k002321 08/14/2000
magic mobility 4 x 4 wheelchair VESTIL MANUFACTURING CORP. k000796 08/11/2000
cardioset (hardware), model ho4; cardioset scl (software), model v3.01 NEXT MILLENNIUM SOFTWARE SOLUTIONS, INC. k001091 08/10/2000
steerable retrograde cardioplegia cannula with and without duraflo treatment, models srco14mib, diisrco14mib EDWARDS LIFESCIENCES, LLC. k001565 08/10/2000
dc zirkon AUSTENAL, INC. k001815 08/10/2000

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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