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FDA 510(k) Applications Submitted by REGENT MEDICAL AMERICAS, LLC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K050184
01/27/2005
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
REGENT MEDICAL AMERICAS, LLC
K050533
03/02/2005
ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE
REGENT MEDICAL AMERICAS, LLC
K050899
04/11/2005
BIOGEL LATEX STERILE POWDER-FREE GLOVE
REGENT MEDICAL AMERICAS, LLC
K053102
11/04/2005
BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
REGENT MEDICAL AMERICAS, LLC
K053441
12/09/2005
BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE
REGENT MEDICAL AMERICAS, LLC
K053442
12/09/2005
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
REGENT MEDICAL AMERICAS, LLC
K053443
12/09/2005
BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE
REGENT MEDICAL AMERICAS, LLC
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