FDA 510(k) Applications Submitted by MARGARET L MARSH
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210135 |
01/19/2021 |
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing |
3M Health Care Business Group |
| K200390 |
02/18/2020 |
V.A.C. DERMATAC Drape |
KCI USA, Inc |
| K120499 |
02/21/2012 |
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K100657 |
03/08/2010 |
V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K100821 |
03/23/2010 |
PREVENA INCISION MANAGEMENT SYSTEM |
KCI USA, INC. |
| K141017 |
04/21/2014 |
PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K111280 |
05/06/2011 |
V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT |
KCI USA, INC. |
| K211521 |
05/17/2021 |
3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) |
3M Health Care Business Group |
| K221585 |
06/01/2022 |
3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit |
3M Health Care Business Group |
| K091585 |
06/02/2009 |
VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 |
KCI USA, INC. |
| K161897 |
07/11/2016 |
PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K062227 |
08/02/2006 |
V.A.C. THERAPY SYSTEM |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K983240 |
09/15/1998 |
NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES |
JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. |
| K162790 |
10/04/2016 |
V.A.C.ULTA Negative Pressure Wound Therapy System |
KCI USA, Inc. (Kinetic Concepts, Inc.) |
| K103156 |
10/26/2010 |
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| K153199 |
11/02/2015 |
Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack |
KCI USA, INC. |
| K173426 |
11/02/2017 |
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System |
KCI USA, INC. |
| K203316 |
11/10/2020 |
V.A.C.ULTA Negative Pressure Wound Therapy System |
KCI, a part of 3M Health Care Business Group |
| K063692 |
12/13/2006 |
V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 |
KCI USA, INC. |
| K043482 |
12/17/2004 |
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116 |
STERIS Corporation |
| K063740 |
12/18/2006 |
V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 |
KCI USA, INC. |
| K961632 |
04/29/1996 |
MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES |
JOHNSON & JOHNSON MEDICAL, INC. |
| K962986 |
08/01/1996 |
MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES |
JOHNSON & JOHNSON MEDICAL, INC. |
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