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510(k) K915357

Device
Promeon Hydrogel Dressing #45 Sterile W/o Mesh
Applicant
MEDTRONIC VASCULAR
510(k) number
K915357
Product code
NAE
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-28
Date received
1991-11-27
Regulation
878.4022
Classification name
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
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
DAVID H MUELLER
Address
6700 Shingle Creek Pky Brooklyn Center MN US 55430 55430

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NAE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K083721MODIFICATION TO ZENIEVARiver'S Edge Pharmaceuticals, LLC2009-01-08
K082865MODIFICATION TO ZENIEVAGorbec Pharmaceutical Services, Inc.2008-10-23
K073246ZENIEVAGorbec Pharmaceutical Services, Inc.2008-07-23
K992094GILTECH PLUS HYDROGEL SKIN DRESSINGGiltech Plus, Inc.1999-09-17
K991061DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGDermaphylyx, Inc.1999-06-28
K972646AD-HEAL HYDROGEL DRESSING, VARIOUS SIZESLudlow Technical Products1997-08-21
K971597COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)Coloplast Corp.1997-07-29
K962352HYDROGEL SKIN DRESSINGNorth American Sterilization & Packaging Co.1996-08-02
K952945AQUAFLO HYDROGEL WOUND DRESSING & PACKERSherwood Medical Co.1995-08-23
K951166BIODERM MEDICAL HYDROGEL ISLAND DRESSINGBioderm, Inc.1995-06-21
K950412CURAGEL HYDROGEL WOUND DRESSINGKendall Healthcare Products Co. Div.Of Tyco Health1995-03-24
K945832BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGSBrady Medical Products Co.1995-03-01
K942748INTRASITESmith & Nephew United, Inc.1994-06-29
K941019BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSINGBrady Medical Products Co.1994-05-04
K934601NDM HYDROGAUZE WOUND DRESSINGNdm Acquisition Corp.1994-02-15