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510(k) Data Aggregation
K Number
K091338Device Name
COLLASORB COLLAGEN WOUND DRESSING
Manufacturer
Date Cleared
2009-08-26
(112 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HARTMANN-CONCO INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CollaSorb™ Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including:
- Pressure ulcers .
- Diabetic ulcers
- Ulcers caused by mixed vascular etiologies
- Venous ulcers
- Second degree burns
- Donor and graft sites
- Abrasions
- Dehisced surgical wounds
- Traumatic wounds healing by secondary intention
Device Description
CollaSorb™ wound dressing is a wound care product composed of a native collagen and calcium-alginate, which comes as a sterile, non-pyrogenic product for single use in a single pouch package.
CollaSorb 10 wound dressings are pliable, absorbent dressings that absorb moisture such as wound fluid by forming a soft, conformable moist gel sheet at the wound surface and thus maintaining a moist environment. Due to its excellent wet stability and elasticity the CollaSorb 100 wound dressing can easily be applied and fitted to the wounds and is also for the management of deep wounds.
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