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Found 7 results
510(k) Data Aggregation
K Number
K102403Device Name
SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
Manufacturer
SAM MEDICAL PRODUCTS
Date Cleared
2011-03-03
(191 days)
Product Code
NAD
Regulation Number
878.4020Why did this record match?
Product Code :
NAD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used as an occlusive wound dressing. To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds, and to be used in emergency situations and to be left in place only while the patient is transported to the hospital.
Device Description
SAM Chest Seal with Valve: The SAM Chest Seal with valve is an adhesive dressing composed of a hydrogel based adhesive with a clear backing and check valve. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound. The one way valve prevents air pressure from increasing in the pleural space.
SAM Chest Seal: The SAM Chest Seal is an adhesive dressing composed of a hydrogel based adhesive with a clear backing. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound.
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K Number
K091133Device Name
APLION TOPICAL CARE SYSTEM
Manufacturer
APLION MEDICAL,LLC
Date Cleared
2009-05-20
(30 days)
Product Code
NAD
Regulation Number
878.4020Why did this record match?
Product Code :
NAD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aplion Topical Care System is an occlusive wound dressing which is intended to provide a moist wound healing environment to facilitate the normal wound healing process. It also permits the introduction of topical wound treatment solutions and suspensions.
Device Description
An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gasses such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing (21 CFR 878.4020).
The Aplion Topical Care System ("Aplion System") consists of an occlusive wound dressing, a tubeset connection, and a small fluid-delivery component.
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K Number
K072560Device Name
ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
Manufacturer
TEIKOKU PHARMA USA, INC.
Date Cleared
2008-06-17
(280 days)
Product Code
NAD
Regulation Number
878.4020Why did this record match?
Product Code :
NAD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- For use in the management of psoriasis and the protection of psoriatic plaques
- As a protective dressing
- For management of superficial, dry to lightly exudating dermal wounds.
Device Description
Envela™ is substantially similar in terms of component materials, shape, dimensions, and mode of action to existing occlusive wound dressings.
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K Number
K060046Device Name
DERMASTREAM
Manufacturer
ENZYSURGE, LTD.
Date Cleared
2006-02-27
(52 days)
Product Code
NAD
Regulation Number
878.4020Why did this record match?
Product Code :
NAD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments such as irrigating solutions, antimicrobial and enzymatic debriding solutions, suspensions, and other solutions. It is intended to provide a moist healing environment and allow debridement to facilitate the normal wound healing process.
Device Description
The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments. It is provided as a sterile, single-use, disposable device.
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K Number
K020781Device Name
WET CHAMBER
Manufacturer
KINETIC CONCEPTS, INC.
Date Cleared
2002-05-06
(56 days)
Product Code
NAD
Regulation Number
878.4020Why did this record match?
Product Code :
NAD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KCI Wound Cell Transparent Dressing is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Dressing may also be used as a secondary fixation device for other topical wound treatments such as antimicrobial and enzymatic debriding solutions and suspensions, alginates, gels and foams.
The KCI Wound Cell Transparent Dressing is indicated for:
- Non-exudating to minimally exuding wounds
- Pressure sores
- Lacerations/abrasions
- Partial and full thickness wounds
- Surgical incisions
- Second degree burns
- Donor sites
- IV sites
Device Description
Occlusive Wound Dressing (21 CFR 878.4020)
The KCI occlusive wound dressings differ in that the Wound Cell includes an injection port. This injection port facilitates the application of topical wound care products after the wound dressing has been placed over the wound to serve as a secondary fixation device in addition to its other intended uses.
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K Number
K990530Device Name
KERLIX MD ANTIMICROBIAL GAUZE DRESSING
Manufacturer
THE KENDALL COMPANY, L.P.
Date Cleared
2000-01-31
(346 days)
Product Code
NAD
Regulation Number
878.4020Why did this record match?
Product Code :
NAD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KERUX Antimicrobial Gauze is intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing
Device Description
The proposed Kerlix MD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of gauze treated with Polyhexamethylene Biguanide Hydrochloride. The dressing is packaged in Tyvek/Poly pouches as well as Tyvek/Styrene trays and is available in both sponge and roll form.
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K Number
K964534Device Name
OTOSILK OTOLOGICAL GRAFT DRESSING
Manufacturer
BOSTON MEDICAL PRODUCTS, INC.
Date Cleared
1997-04-09
(148 days)
Product Code
NAD
Regulation Number
878.4020Why did this record match?
Product Code :
NAD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used as a temporary dressing in the external auditory canal following tympanoplasty or stapedectomy procedures.
Device Description
The OTOSILK™ Graft Dressing is a sterile, disposable graft dressing constructed of non-adherent material, designed for use with split thickness skin grafts used in procedures such as tympanoplasty, canalplasty, mastoid tympanoplasty, correction of congenital aural atresia, and removal of canal exostoses.
Split thickness skin grafts may be taken from several sites, using either a razor blade or dermatome. The OTOSILK dressing will be used as a carrier for this skin graft to the ear canal. The graft is placed dermis side up on the dressing and the uncovered material is trimmed away. The skin graft and dressing are then applied to the canal. The dressing is removed from the canal one to two weeks post-operatively. The blue color of the OTOSILK Graft Dressing increases visualization of the dressing, ensuring total removal from the ear canal without disturbing the graft.
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