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510(k) K983394

Device
MODIFICATION TO TIELLE HYDROPOLMER DRESSING
Applicant
JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC.
510(k) number
K983394
Product code
MGP  
Decision
Substantially Equivalent (SESE)
Decision date
1998-11-03
Date received
1998-09-25
Regulation
510(k) Premarket Notification
Classification name
Dressing, Wound And Burn, Occlusive
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TERRY J DAGNON
Address
2500 Arbrook Bl Arlington TX US 76004 76004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MGP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K012995COLLATEK SHEETBiocore Medical Technologies, Inc.2001-10-25
K012997COLLATEK FOAMBiocore Medical Technologies, Inc.2001-10-25
K001508LASERSKIN DRESSINGFidia Advanced Biopolymers Srl2001-07-25
K990079FASTSEAL CHEST WOUND DRESSINGGreenfield Medical Technologies, Inc.1999-12-23
K991214SIMPLICARE TRANSPARENT WOUND DRESSINGHollister, Inc.1999-10-14
K992302DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORSDermaphylyx, Inc.1999-09-14
K992005GILTECH PLUS TRANSPARENT DRESSINGGiltech Plus, Inc.1999-09-03
K990875DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSINGDermaphylyx, Inc.1999-05-27
K990438DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSINGDermaphylyx, Inc.1999-03-25
K984371MEPITEL NON ADHERENT SILICONE DRESSINGMolnlycke Health Care, Inc.1999-03-03
K983303INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGSInnovative Technologies , Ltd.1998-12-09
K983234TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSINGJohnson & Johnson Medical, Div. of Ethicon, Inc.1998-11-25
K983184MEPILEXMolnlycke Health Care, Inc.1998-10-28
K974891ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013Acutek Adhesive Specialties, Inc.1998-10-21
K982939BTF THIN FILM WOUND DRESSINGBioderm, Inc.1998-10-13

Legacy Summary#

summary

FDA Review#

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