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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 K191987
Device Name Orapeutic
Applicant
Forward Science
10401 Greenbough
Suite 100
Stafford,  TX  77477
Applicant Contact Brian Pikkula
Correspondent
Forward Science
10401 Greenbough
Suite 100
Stafford,  TX  77477
Correspondent Contact Brian Pikkula
Classification Product Code
OLR  
Date Received07/25/2019
Decision Date 11/27/2019
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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