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510(k) Data Aggregation
K Number
K210751Device Name
S.E.A.L. Hemostatic Wound Spray
Manufacturer
Date Cleared
2023-02-02
(692 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BC3 Technologies Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Prescription Use:
S.E.A.L. Hemostatic Wound Spray is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.
OTC:
S.E.A.L. Hemostatic Wound Spray is indicated for the local management of minor bleeding such as minor lacerations, minor cuts and minor abrasions.
Device Description
S.E.A.L. Hemostatic Wound Spray is composed of chitosan dry powder in spray form that provides a physical barrier or seal to stop the flow of blood. When sprayed on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound. S.E.A.L. quickly forms a strong seal that completely covers the wound. S.E.A.L. is presented for both Prescription and over-the-counter (OTC) use.
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