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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 K251908
Device Name Emanate Tray
Applicant
Emanate Biomedical
45 Rockefeller Plz.
19th Floor
New York,  NY  10111
Applicant Contact Jarret Fass
Correspondent
Emanate Biomedical
45 Rockefeller Plz.
19th Floor
New York,  NY  10111
Correspondent Contact Jarret Fass
Classification Product Code
OLR  
Date Received06/20/2025
Decision Date 07/29/2026
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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