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510(k) K936186

Device
AESCULAP SKIN GRAFT MESHER
Applicant
AESCULAP, INC.
510(k) number
K936186
Product code
FZW  
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-10
Date received
1993-12-23
Regulation
878.4800
Classification name
Expander, Surgical, Skin Graft
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARY ELLEN HOLDEN
Address
1000 Gateway Blvd. South San Francisco CA US 94080 94080

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FZW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K080158LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEMLb Medical LLC2008-05-02
K984448BIRCOLL BALLOON DISSECTORWells Johnson Co.1999-01-28
K972109SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDERGeneral Surgical Innovations1997-11-14
K904265INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDERInamed Development Co.1991-03-06
K902349SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDERSurgitek1990-09-05
K883303MENTOR RAPID-SPAN (TM) TISSUE EXPANDERMentor Corp.1988-08-26
K874276CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDERCox-Uphuff Intl.1987-12-02

Legacy Summary#

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FDA Review#

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