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510(k) K243875

Spectricept Skin and Wound Cleanser by Spectrum Antimicrobials, Inc. — Product Code FRO

K243875 is an FDA 510(k) premarket notification submitted by Spectrum Antimicrobials, Inc. for the device "Spectricept Skin and Wound Cleanser". The FDA issued a decision of Substantially Equivalent on Apr 21, 2025. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 21, 2025
Date Received
Dec 17, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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FDA data resources