DEMETECH CORP.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1064584	3003063934	DEMETECH CORP.	1	N	2026-01-01	5980 Miami Lakes Drive Miami Lakes FL US 33014

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
57768	1611771200	K201479	DemeMASK	FXX	2020-07-24
57768	1102679360	K191361	DemeDIOX Barbed Absorbable Surgical Suture	NEW	2019-11-07
57768	1130205140	K190777	DemeTECH DemeFORCE Nonabsorbable Surgical Suture	GAT	2019-07-31
57768	1903886908	K181582	DemeTECH DemeDIOX absorbable surgical suture	NEW	2018-08-27
57768	1323798094	K181578	DemeTECH PTFE Nonabsorbable Surgical Suture	NBY	2018-10-11
57768	2052185467	K141007	DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE	GAQ	2014-09-25
57768	1436328531	K130083	DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE	GAM	2013-07-17
57768	1383660967	K123940	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	GAM	2014-05-30
57768	1599878587	K082097	DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE	NEW	2010-01-08
57768	1740119731	K072930	DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT	GAL	2008-04-30
57768	1616270018	K060018	TRULENE MESH	FTL	2006-07-26
57768	1995503269	K043539	DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES	GAM	2005-04-06
57768	1637696881	K043330	POLYPROPILENE SURGICAL SUTURES	GAW	2005-05-16
57768	1238936151	K023030	DEMETECH POLYESTER NONABSORBABLE SUTURE	GAT	2003-06-18
57768	1241537604	K023029	DEMETECH SILK NONABSORBABLE SUTURE	GAP	2002-11-25
57768	1780338658	K023028	DEMETECH NYLON NONABSORBABLE SUTURE	GAR	2003-06-18
57768	1065546781
57768	1424429748
57768	1831831129
57768	1114215952
57768	1305862716
57768	1338279714
57768	1351081382
57768	1726728991
57768	1735500436
57768	1787618322
57768	2019078303

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NEW	3	2019-11-07
GAM	3	2014-05-30
GAT	2	2019-07-31
FXX	1	2020-07-24
NBY	1	2018-10-11
GAQ	1	2014-09-25
GAL	1	2008-04-30
FTL	1	2006-07-26
GAW	1	2005-05-16
GAR	1	2003-06-18
GAP	1	2002-11-25

PMN#

DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
2014-09-25
DEMETECH CORP.
DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
2014-05-30
DEMETECH CORP.
DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE
2013-07-17
DEMETECH CORP.
DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
2010-01-08
DEMETECH CORP.
DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
2008-04-30
DEMETECH CORP.
POLYPROPILENE SURGICAL SUTURES
2005-05-16
DEMETECH CORP.
DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
2005-04-06
DEMETECH CORP.
DEMETECH POLYESTER NONABSORBABLE SUTURE
2003-06-18
DEMETECH CORP.
DEMETECH NYLON NONABSORBABLE SUTURE
2003-06-18
DEMETECH CORP.
DEMETECH SILK NONABSORBABLE SUTURE
2002-11-25
DEMETECH CORP.