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510(k) Data Aggregation
K Number
K103648Device Name
COLLAGEN POWDER
Manufacturer
INNOCOLL PHARMACEUTICALS LTD
Date Cleared
2011-09-14
(274 days)
Product Code
KGN, CLA
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
INNOCOLL PHARMACEUTICALS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collagen Powder may be used for the management of wounds such as:
- Diabetic ulcers
- Venous ulcers
- Pressure ulcers
- Ulcers caused by mixed vascular etiologies
- Full-thickness & partial thickness wounds
- Abrasions
- Traumatic wounds
- 1st and 2nd degree burns
- Dehisced surgical wounds
- Exuding wounds
Device Description
Collagen Powder is a collagen matrix in powder form intended for application as a wound management device. The product is supplied sterile for single use only.
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K Number
K110388Device Name
COLLACARE DENTAL
Manufacturer
INNOCOLL PHARMACEUTICALS LTD
Date Cleared
2011-08-09
(180 days)
Product Code
KGN, CLA
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
INNOCOLL PHARMACEUTICALS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collacare Dental is indicated for the management of oral wounds and sores, including:
- denture sores
- oral ulcers (non-infected or viral)
- periodontal surgical wounds
- suture sites
- burns
- surgical wounds and traumatic wounds
Device Description
Collacare Dental is a conformable collagen matrix manufactured from purified type I collagen derived from bovine Achilles tendon. Collacare Dental is supplied sterile and non-pyrogenic, in various sizes, and for single use only.
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