FDA 510(k) Applications for Medical Device Product Code "FZW"
(Expander, Surgical, Skin Graft)

FDA 510(k) Number Applicant Device Name Decision Date
K972109 GENERAL SURGICAL INNOVATIONS SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER 11/14/1997
K080158 LB MEDICAL L.L.C. LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM 05/02/2008
K984448 WELLS JOHNSON CO. BIRCOLL BALLOON DISSECTOR 01/28/1999


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