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510(k) Data Aggregation
K Number
K140456Device Name
BIO-CONNEKT WOUND MATRIX
Manufacturer
Date Cleared
2014-07-22
(148 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MLM BIOLOGICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MLM Biologics bio-ConneKt Wound Matrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:
- · Partial and full thickness wounds
- · Draining wounds
- Tunneling wounds
- Pressure sores/ulcers
- Venous ulcers
- · Chronic vascular ulcers
- Diabetic ulcer
· Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears)
· Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, podiatric wounds, dehisced surgical incisions)
Device Description
The bio-ConneKt Wound Matrix is a sterile, conformable and porous wound dressing made of reconstituted collagen derived from equine tendon. It is chemically crosslinked to provide resistance to enzymatic degradation. The dressing is provided sterile for single use only.
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