FDA 510(k) Applications Submitted by GENZYME CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K043035 11/03/2004 SEPRAGEL ENT BIORESORBABLE PACKING/STENT GENZYME CORPORATION
K102242 08/09/2010 OSOM C. DIFFICILE TOXIN A/B TEST GENZYME CORPORATION
K080662 03/10/2008 GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR GENZYME CORPORATION
K092633 08/27/2009 OSOM INFLUENZA A&B TEST , MODEL PN190 GENZYME CORPORATION
K053066 11/01/2005 SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH GENZYME CORPORATION
K063739 12/18/2006 SEPRAMESH, MODEL 5959-1214 GENZYME CORPORATION


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact