FDA 510(k) Applications Submitted by Kenneth K. Kleinhenz

FDA 510(k) Number Submission Date Device Name Applicant
K041105 04/30/2004 MACROPORE HYDROSORB SPINE SYSTEM MACROPORE BIOSURGERY, INC.
K072587 09/14/2007 CYTORI AFT SYSTEM CYTORI THERAPEUTICS, INC.
K090160 01/22/2009 SUPRATHEL WOUND AND BURN DRESSING POLYMEDICS INNOVATIONS GMBH
K090271 02/04/2009 HYDROCOAT MESH PROMETHEAN SURGICAL DEVICES, INC.
K050332 02/10/2005 SURGI-WRAP MAST BIORESORBABLE SHEET MAST BIOSURGERY USA INC.
K160414 02/16/2016 Precision Point Biopsy Needle Guide Corbin Clinical Resources, LLC
K060482 02/23/2006 CYTORI CELUTION CELL CONCENTRATION DEVICE CYTORI THERAPEUTICS, INC.
K000696 03/01/2000 MACROPOREMX MANDIBULAR FIXATION SYSTEM MACROPORE BIOSURGERY, INC.
K090637 03/10/2009 CARDIO-WRAP MAST BIOSURGERY USA INC.
K010911 03/26/2001 MACROPORE OS SPINAL SYSTEM MACROPORE BIOSURGERY, INC.
K000992 03/28/2000 MACROPOREDX DISTRACTOR SYSTEM MACROPORE BIOSURGERY, INC.
K021164 04/11/2002 MACROPORE OS TRAUMA MACROPORE BIOSURGERY, INC.
K061473 05/30/2006 SURGI-WRAP MAST BIORESORBABLE SHEET MAST BIOSURGERY USA INC.
K011715 06/04/2001 MACROPORE IB RESORBABLE PLUG MACROPORE BIOSURGERY, INC.
K031785 06/10/2003 MACROPORE CARDIO-WRAP (TS) MACROPORE BIOSURGERY, INC.
K031955 06/25/2003 MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET MACROPORE BIOSURGERY, INC.
K012025 06/28/2001 MACROPORE SURGIWRAP (TS) MACROPORE BIOSURGERY, INC.
K002207 07/21/2000 MACROPOREPX PEDIATRIC SYSTEM MACROPORE BIOSURGERY, INC.
K012413 07/30/2001 MACROPORE FX, PS, NS, LP MACROPORE BIOSURGERY, INC.
K072190 08/06/2007 ORTHO-WRAP BIORESORBABLE SHEET MAST BIOSURGERY
K012769 08/17/2001 MACROPORE ENT RECONSTRUCTION FILM MACROPORE BIOSURGERY, INC.
K042261 08/23/2004 MACROPORE PURICEL LIPOPLASTY SYSTEM MACROPORE BIOSURGERY, INC.
K132815 09/09/2013 PUREGRAFT 50 SYSTEM CYTORI THERAPEUTICS, INC.
K092923 09/23/2009 CYTORI PUREGRAFT 250/PURE SYSTEM CYTORI THERAPEUTICS, INC.
K063235 10/25/2006 CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT CYTORI THERAPEUTICS, INC.
K023643 10/30/2002 MACROPORE SURGICAL BARRIER FILM MACROPORE BIOSURGERY, INC.
K113255 11/03/2011 PUREGRAFT 850/PURE SYSTEM CYTORI THERAPEUTICS, INC.
K123446 11/08/2012 TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM United States GTM Medical Devices, Inc.
K063648 12/07/2006 SURGI-WRAP MAST TENDON SHEET MAST BIOSURGERY USA INC.
K024169 12/18/2002 MACROPORE OS RECONSTRUCTION MACROPORE BIOSURGERY, INC.
K170213 01/24/2017 SupraSDRM Biodegradable Matrix Wound Dressing PolyMedics Innovations GmbH
K160423 02/16/2016 Perineologic Access Needle Corbin Clinical Resources, LLC


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