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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 K221428
Device Name PerioStom Dental Dressing
Applicant
Forward Science LLC
10810 Criaghead Dr
Houston,  TX  77025
Applicant Contact Brian Pikkula
Correspondent
Forward Science LLC
10810 Criaghead Dr
Houston,  TX  77025
Correspondent Contact Brian Pikkula
Classification Product Code
OLR  
Subsequent Product Code
MGQ  
Date Received05/16/2022
Decision Date 12/22/2022
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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