FDA 510(k) Applications Submitted by Coloplast Corp.

FDA 510(k) Number Submission Date Device Name Applicant
K121457 05/16/2012 SPEEDICATH COMPACT SET (12 FR) COLOPLAST CORP.
K022416 07/24/2002 CONTREET FOAM ADHESIVE/NON-ADHESIVE COLOPLAST CORP.
K052229 08/16/2005 COLOPLAST OSTOMY ROD, MODEL 12814 COLOPLAST CORP.
K023254 09/30/2002 SPEEDICATH COLOPLAST CORP.
K033869 12/12/2003 CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) COLOPLAST CORP.
K991202 03/22/1999 MODIFICATION TO WOUN'DRES COLOPLAST CORP.
K983042 08/31/1998 SWEEN WOUN'DRES COLOPLAST CORP.
K013525 10/23/2001 CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) COLOPLAST CORP.
K983163 09/10/1998 BIATAIN FOAM DRESSING COLOPLAST CORP.
K983173 09/10/1998 BIATAIN FOAM ADHESIVE DRESSING COLOPLAST CORP.
K983519 10/08/1998 COMFEEL SEASORB DRESSING COLOPLAST CORP.
K122968 09/25/2012 NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 COLOPLAST CORP.
K161672 06/09/2016 SpeediCath Flex Coude Coloplast Corp.
K072808 10/01/2007 SPEEDICATH COMPACT COLOPLAST CORP.
K971597 05/01/1997 COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) COLOPLAST CORP.
K982493 07/17/1998 COMPEED PSORIASIS DRESSING COLOPLAST CORP.
K973070 08/18/1997 CONVEEN EASICATH SET COLOPLAST CORP.
K132061 07/03/2013 RESTORELLE M, RESTORELLE XL COLOPLAST CORP.
K122440 08/10/2012 RESTORELLE L COLOPLAST CORP.
K112386 08/18/2011 EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM COLOPLAST CORP.


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