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510(k) Data Aggregation
K Number
K101118Device Name
ACTIVON TULLE
Manufacturer
Date Cleared
2010-12-15
(238 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CALIDAD SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OTC: For minor wounds, ulcerations and burns, abraded skin, and irritated areas.
Professional: Intended in the management of:
- diabetic foot ulcers;
- leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
- pressure ulcers/sores (partial and full thickness);
- 1st and 2nd degree partial thickness burns;
- grafted and donor sites and traumatic and surgical wounds.
Device Description
Activon Tulle is a sterile wound care dressing for use in moist wound management. Activon Tulle is offered as 2x2 inch and 4x4 inch non-adherent knitted viscose primary dressing impregnated with 100% Manuka honey for effective wound treatment.
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