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510(k) K003948

Device
EPI-DERM SILICONE GEL SHEETING
Applicant
BIODERMIS CORP.
510(k) number
K003948
Product code
MDA  
Decision
Substantially Equivalent (SESE)
Decision date
2001-01-29
Date received
2000-12-21
Regulation
878.4025
Classification name
Elastomer, Silicone, For Scar Management
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
JEFF S SCHLEUING
Address
3078 E. Sunset Rd. Suite #1 Las Vegas NV US 89120 89120

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MDA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.2011-09-29
K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.2011-09-22
K083718BEAU RX SCAR CARE GELBeau RX Solutions, LLC2009-01-26
K053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.2006-04-14
K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.2005-10-17
K040307HANSON SCAR ADEHanson Medical, Inc.2004-08-12
K024057CURAD SCAR THERAPYBeiersdorf, Inc.2003-06-18
K024160NEOSPORIN SCAR SOLUTIONWarner-Lambert Co.2003-03-17
K023678DIMISIL SCAR GELAesthetic and Reconstructive Technologies, Inc.2003-01-23
K023136OLEEVA FABRICBio Med Sciences, Inc.2002-10-16
K014036MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.Medtrade Products , Ltd.2002-02-14
K013732GELZONEImplantech Associates, Inc.2002-02-07
K012419CONFORM SHEETING, MODEL IGELImplantech Associates, Inc.2001-10-24
K010675ENSIL FABRICGottfried Medical, Inc.2001-05-30
K010245ACTIVHEAL SCAR MANAGEMENT DRESSINGAdvanced Medical Solutions, Ltd.2001-04-25

Legacy Summary#

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FDA Review#

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