FZW — Expander, Surgical, Skin Graft Class I

FDA Device Classification

Classification Details

Product Code
FZW
Device Class
Class I
Regulation Number
878.4800
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K080158lb medicalLB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEMMay 2, 2008
K984448wells johnsonBIRCOLL BALLOON DISSECTORJanuary 28, 1999
K972109general surgical innovationsSPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDERNovember 14, 1997
K936186aesculapAESCULAP SKIN GRAFT MESHERMarch 10, 1994
K904265inamed developmentINAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDERMarch 6, 1991
K902349surgitekSURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDERSeptember 5, 1990
K883303mentorMENTOR RAPID-SPAN (TM) TISSUE EXPANDERAugust 26, 1988
K874276cox-uphuff intlCUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDERDecember 2, 1987