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510(k) Data Aggregation
K Number
K110172Device Name
SONAFINE WOUND DRESSING
Manufacturer
STRATUS PHARMACEUTICAL
Date Cleared
2011-08-19
(211 days)
Product Code
FRO, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
STRATUS PHARMACEUTICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SONAFINE® Wound Dressing is indicated for topical use in the management of full and partial thickness wounds including dermal ulcers, superficial wounds, first and second degree burns and donor sites to include:
- Radiation Dermatitis
- Various types of dermatoses
- Atopic dermatitis
- Allergic contact dermatitis
- Dry waxy skin
SONAFINE® Wound Dressing maintains a moist wound and skin environment.
Indications for OTC use:
SONAFINE® Wound Dressing is indicated for the management of minor cuts, minor burns, and minor lacerations.
SONAFINE® Wound Dressing maintains a moist wound and skin environment.
Device Description
SONAFINE® Wound Dressing is a preserved emulsion intended to be used as a topically applied preparation to breached and intact skin and is provided in a patient ready, 28 gram (one (1) ounce), 45 gram and 90 gram collapsible tube.
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