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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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palamed g HERAEUS KULZER GMBH k050855 07/07/2005
flexible video cystoscope/choledochoscope, models 7308.061 and 7308.066 RICHARD WOLF MEDICAL INSTRUMENTS CORP. k051176 10/05/2005
med flash ii intense pulsed light system. GENERAL PROJECT S.R.L. k051508 10/05/2005
whole pth (1-84) specific immunoradiometric assay (irma) coated tube kit, model 3kg014 SCANTIBODIES LABORATORY, INC. k051810 09/09/2005
modus imf screws 2.0 MEDARTIS, INC. k052061 10/21/2005
drystar model 5500 AGFA CORPORATION k052251 08/31/2005
mesa spinal system K2M, LLC k052398 12/07/2005
one step fsh menopausal test IND DIAGNOSTIC INC. k052662 11/30/2005
profemur xtr hip stem WRIGHT MEDICAL TECHNOLOGY, INC. k052915 01/27/2006
rm3 renal preservation system WATERS INSTRUMENTS, INC. k053169 01/17/2006

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