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510(k) Data Aggregation
K Number
K071519Device Name
HEMCON CHITOFLEX-SURGICAL DRESSING
Manufacturer
HEMCON, INC.
Date Cleared
2007-08-06
(63 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HEMCON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HemCon ChitoFilex™ Surgical is intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.
It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatalogical, etc.) and traumatic injuries.
Device Description
The HemCon ChitoFlex™-Surgical Dressing is a sterile chitosan based dressing intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.
It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatalogical, etc.) and traumatic injuries.
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K Number
K060363Device Name
HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
Manufacturer
HEMCON, INC.
Date Cleared
2006-07-07
(144 days)
Product Code
OLR, MGQ, UNC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HEMCON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HemCon® Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
Device Description
The HemCon® Dental Dressing is identical in material, design and composition to the legally marketed HemCon® Bandage (K023298, cleared 04 November 2002 with update K043050, cleared 03 June 2005). The only differences are the indication for use in the oral cavity and the reduction in size for the use in the oral cavity (10 cm x 10 cm for the legally marketed HemCon® bandage versus 10 mm x 12 mm for the dental dressing). Additionally, the HemCon® Dental Dressing is provided without the non-stick backing used on the HemCon® Bandage.
The HemCon® Dental Dressing is a lyophilized (freeze-dried) chitosan-based dressing designed to optimize the mucoadhesive surface density and structural integrity of chitosan at the wound site. The HemCon® Dental Dressing may be manufactured to any size and is currently available in 10 mm x 12 mm rectangular dressing and is packaged in a vacuum-sealed aluminum pouch and processed with gamma radiation for sterile single-use only application.
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K Number
K043050Device Name
HEMCON BANDAGE AND HEMCON BANDAGE OTC
Manufacturer
HEMCON, INC.
Date Cleared
2005-06-03
(211 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HEMCON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HemCon® Bandage is intended as an external temporary wound treatment for the control of severely bleeding wounds for emergency use. In addition, the HemCon® Bandage also controls bleeding in patients following hemodialysis. The HemCon® Bandage OTC is intended for the local management of bleeding such as laceration and minor bleeding.
Device Description
The HemCon® Bandage and the HemCon® Bandage OTC are each applied to the wound and held in place until it adheres to the wound and hemostasis is achieved. Then, an outer bandage is applied to secure the dressing on the wound site. The HemCon® Bandage and the HemCon® Bandage OTC are manufactured from chitosan, a material consisting of cellulosic polymer, poly[ß(1->4)-2-amino-2-deoxy-D-dlucopyranose]. These devices are packaged in a foil package and provided sterile. They are sterilized by gamma irradiation at a dose adequate to ensure a SAL of 10 %.
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K Number
K030946Device Name
HEMCON BANDAGE OTC; HEMCON CATH/AID
Manufacturer
HEMCON, INC.
Date Cleared
2003-06-19
(85 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HEMCON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HemCon™ Bandage OTC Is indicated for the local management of bleading such as laceration and minor bleeding.
Device Description
The HemCon™ Bandage OTC is manufactured from chilosan, a material consisting of callulosic polymer, poly-N-acetylgiucosamine. The HemCon™ Bandage OTC device is packaged in a foll package and are provided sterile.
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K Number
K023298Device Name
HEMCON BANDAGE
Manufacturer
HEMCON, INC.
Date Cleared
2002-11-04
(32 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HEMCON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HemCon™ Bandage is a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon™ Bandage also controls bleeding in patients following hemodialysis.
Device Description
The HemCon™ Bandage is applied to the wound and held in place until it adheres to the wound and hemostasis is achieved. Then, an outer bandage is applied to secure the dressing on the wound site. The HemCon™ Bandage is manufactured from ChitoClear™ chitosan ,a material consisting of cellulosic polymer, poly-N-acetylglucosamine. This device is packaged in a foil package and is provided sterile. It is sterilized by gamma irradiation at 15 kGy ensuring a SAL of 10°.
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