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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 K252568
Device Name New Day Skin Spray
Applicant
Silk Holdings, Inc.
117 Kendrick St. #700
Needham,  MA  02494
Applicant Contact Suzanne Cheang
Correspondent
Silk Holdings, Inc.
117 Kendrick St. #700
Needham,  MA  02494
Correspondent Contact Rebecca L Lacouture
Classification Product Code
FRO  
Date Received08/14/2025
Decision Date 01/23/2026
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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