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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Wound Dressing
510(k) Number K260120
Device Name NaturaJel™ Oral Wound Care Kit
Applicant
HCS Innovation, LLC
384 Highlands Ct.
Union Grove,  AL  35175
Applicant Contact Ronnie Hanes
Correspondent
HCS Innovation, LLC
384 Highlands Ct.
Union Grove,  AL  35175
Correspondent Contact Peter Catalano
Classification Product Code
OLR  
Date Received01/15/2026
Decision Date 08/05/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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