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510(k) Data Aggregation
K Number
K201479Device Name
DemeMASK
Manufacturer
DemeTECH Corporation
Date Cleared
2020-07-24
(50 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
DemeTECH Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
Device Description
The proposed devices are 3-ply, flat-pleated surgical masks. The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There surgical masks to be secured on users via earloops made of spandex and nylon. The devices are sold non-sterile and are intended to be single use and disposable.
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K Number
K191361Device Name
DemeDIOX Barbed Absorbable Surgical Suture
Manufacturer
DemeTECH Corporation
Date Cleared
2019-11-07
(170 days)
Product Code
NEW
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
DemeTECH Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DemeDIOX Barbed polydioxanone suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
Device Description
DemeDIOX Barbed Absorbable Surgical Suture is an absorbable, sterile surgical monofilament suture composed of polyester, poly (p-dioxanone). The DemeTECH Suture meets all requirements in the latest edition of the USP monograph for absorbable surgical sutures with the exception of diameter. DemeDIOX Barbed Suture consists of an absorbable monofilament strand thread with spiral unidirectional barbs and is available with or without needles in a suture size 5-0 to 2. The material is dyed with D&C Violet No.2. and contains no additives. The barbing allows for tissue approximation without the use of surgical knots.
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K Number
K190777Device Name
DemeTECH DemeFORCE Nonabsorbable Surgical Suture
Manufacturer
DemeTECH Corporation
Date Cleared
2019-07-31
(127 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
DemeTECH Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DemeFORCE Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Device Description
DemeTECH DemeFORCE Suture is a nonabsorbable, sterile surgical monofilament suture composed of Ultra-high-molecular-weight polyethylene. The DemeTECH UHMWPE Suture meets or exceeds all requirements in the latest edition of the USP monograph for nonabsorbable surgical sutures and is provided sterile in various sizes and configurations. The material is available in different colors and may be provided with or without an attached needle(s).
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K Number
K181578Device Name
DemeTECH PTFE Nonabsorbable Surgical Suture
Manufacturer
Demetech Corporation
Date Cleared
2018-10-11
(118 days)
Product Code
NBY
Regulation Number
878.5035Why did this record match?
Applicant Name (Manufacturer) :
Demetech Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DemeTECH PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery, and peripheral neural tissue.
Device Description
DemeTECH PTFE Suture is a nonabsorbable, sterile surgical monofilament suture composed of polytetrafluoroethylene. The DemeTECH PTFE Suture meets or exceeds all requirements in the latest edition of the USP monograph for nonabsorbable surgical sutures and is provided sterile in various sizes and configurations. The material is undyed and contains no additives and is white in appearance and may be provided with or without an attached needle(s).
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K Number
K181582Device Name
DemeTECH DemeDIOX absorbable surgical suture
Manufacturer
Demetech Corporation
Date Cleared
2018-08-27
(73 days)
Product Code
NEW
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
Demetech Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DemeDIOX Absorbable Surgical Suture is indicated for use in general soft tissue approximation including pediatric cardiovascular tisue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.
Device Description
DemeDIOX Absorbable Surgical Suture is an absorbable, sterile surgical monofilament suture composed of polyester, poly (p-dioxanone). The DemeTECH Suture meets all requirements in the latest edition of the USP monograph for absorbable surgical sutures and the modification from the existence 510k K082097 is that thread is winded around the needle, a foam needle park is applied to the needle to securely hold the needle in place with the thread. One to four needles will be placed in a suture size 6-0, 5cm length, no thread attached to the needle. The material is dyed violet or un-dyed and contains no additives.
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