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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 K202000
Device Name Silatrix Oral Gel
Applicant
SA3, LLC
2317 Cotner Ave
Los Angeles,  CA  90064
Applicant Contact Farbod Melamed
Correspondent
Greenleaf Health, Inc.
1055 Thomas Jefferson Street, NW, Suite 450
Washington,  DC  20007
Correspondent Contact Daniel Schultz
Classification Product Code
OLR  
Subsequent Product Code
FRO  
Date Received07/20/2020
Decision Date 11/20/2020
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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