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510(k) Data Aggregation
K Number
K081724Device Name
HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL
Manufacturer
APPLIED NUTRITIONALS
Date Cleared
2008-10-30
(134 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
APPLIED NUTRITIONALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound gel is indicated for topical use in the management of chronic and acute wounds and dermal ulcers including the local management of:
- Pressure Ulcers (Stage I-IV)
- Venous Stasis Ulcers
- Diabetic Ulcers
- First and Second Degrec Burns
- Surgical wounds
- Traumatic wounds
- Superficial wounds
- Ulcers resulting from arterial insufficiency
- Grafted wounds and donor sites
For over the counter use, Hydrolyzed Collagen with 10% Chondroiiin Sulfate Wound Gel may be used for:
- minor abrasions
- laccrations
- minor cuts
- minor scalds and burns
Device Description
Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound Gel is a line extension of the previously approved HyCure® Hydrolyzed Collagen (K955506). Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) contains Chondroitin Sulfate as Chondroprotec® previously approved for market via 510(k) (K961930). Hydrolyzed Collagcn with 10% Chondroitin Sulfate Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound gel is provided in a patient ready, one (1) ounce, collapsible tube.
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