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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K213514
Device Name Spectricept Skin and Wound Cleanser
Applicant
Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.
1770 Corporate Cir.
Petaluma,  CA  94954
Applicant Contact Hoji Alimi
Correspondent
Dunn Regulatory Associates, LLC
2709 Silkwood Ct.
Oakton,  VA  22124
Correspondent Contact Dana Dunn
Classification Product Code
FRO  
Date Received11/02/2021
Decision Date 01/13/2023
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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