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FDA 510(k) Applications Submitted by JEROME JAMES
FDA 510(k) Number
Submission Date
Device Name
Applicant
K090074
01/12/2009
HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS
HYGIA HEALTH SERVICES, INC.
K080424
02/15/2008
HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861
HYGIA HEALTH SERVICES, INC.
K101280
05/06/2010
MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE
MIDWEST REPROCESSING CENTER LLC
K101330
05/12/2010
MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE
MIDWEST REPROCESSING CENTER LLC
K101702
06/17/2010
MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS
MIDWEST REPROCESSING CENTER LLC
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