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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
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