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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 K260126
Device Name Curajel™ Oral Gel
Applicant
USpharma, Ltd.
13900 NW 57th Ct.
Miami Lakes,  FL  33014
Applicant Contact Rushi Patel
Correspondent
Eliquent Life Sciences, Inc.
1055 Thomas Jefferson St., Suite 450
Washington,  DC  20007
Correspondent Contact Samantha Eakes
Classification Product Code
OLR  
Date Received01/15/2026
Decision Date 06/15/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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