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510(k) Data Aggregation
K Number
K101114Device Name
ADVANCIS ACTIVON TUBE
Manufacturer
Date Cleared
2011-07-26
(461 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Advancis Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OTC: For minor wounds, minor ulcerations, minor burns, minor abraded skin, and minor 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 Tube ™ Sterile 100% Manuka Honey is a wound care dressing for use in moist wound management. The Activon Tube TM Sterile 100% Manuka Honey is offered as a 0.99 oz (2.8 g) twist off cap squeeze tube for one-time use .
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