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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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