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510(k) K965256

Device
DMS-1000C DERMOABRADER
Applicant
MATTIOLI ENGINEERING, SRL
510(k) number
K965256
Product code
GFD  
Decision
Substantially Equivalent (SESE)
Decision date
1996-12-09
Date received
1996-08-16
Regulation
878.4820
Classification name
Dermatome
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GIAN FRANCO BERNABEI
Address
Viale Machiavelli, 2/A Florence IT 50125 50125

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GFD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962371DERMTOME BLADEDsp Worldwide1996-08-29
K945594DECA DERMATOME (MICROMOTOR SYSTEM)Depuy Intl., Ltd.1995-06-05
K951085PADGETT AIR DERMATOME, MODEL APadgett Instruments, Inc.1995-05-15
K940208AESCULAP ACCU-DERMATOMEAesculap, Inc.1994-02-24
K862669ACTIVATED PARTIAL THROMBOPLASTIN TIME TESTU. S. Diagnostics, Inc.1986-10-03
K861285SKIN MESH DEVICEPrecision Modified Devices1986-04-17
K861138MASH DERMATOMEMecron Medical Products, Inc.1986-04-14
K860925DERMASPANDEREMri Ventures, Inc.1986-03-28
K842702ROSENBERG SKIN GRAFTING KNIVESDowns Surgical , Ltd.1984-08-02
K830993AMPLIGREFFEProthia USA, Inc.1983-05-03
K792332DAVOL/SIMON DERMATOMEDavol, Inc.1979-12-06

Legacy Summary#

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FDA Review#

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