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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