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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 K241283
Device Name Elemental Granulate
Applicant
Zinkh NV
Zuiderlaan 1-3
P.O. Box: 8
Gent,  BE 9000
Applicant Contact Emiel Lippens
Correspondent
Zinkh NV
Zuiderlaan 1-3
P.O. Box: 8
Gent,  BE 9000
Correspondent Contact Emiel Lippens
Classification Product Code
OLR  
Subsequent Product Code
EMA  
Date Received05/07/2024
Decision Date 01/03/2025
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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