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510(k) K213514

Spectricept Skin and Wound Cleanser by Spectrum Antimicrobials, Inc. (Subsidiary Of Collidion, Inc. — Product Code FRO

K213514 is an FDA 510(k) premarket notification submitted by Spectrum Antimicrobials, Inc. (Subsidiary Of Collidion, Inc. for the device "Spectricept Skin and Wound Cleanser". The FDA issued a decision of Substantially Equivalent on Jan 13, 2023. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 13, 2023
Date Received
Nov 2, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

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FDA data resources