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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 K203091
Device Name MucoLock Oral Gel
Applicant
PCCA, Inc.
9901 S. Wilcrest Drive
Houston,  TX  77099
Applicant Contact Gus Bassani
Correspondent
PCCA, Inc.
9901 S. Wilcrest Drive
Houston,  TX  77099
Correspondent Contact Gus Bassani
Classification Product Code
OLR  
Date Received10/13/2020
Decision Date 02/12/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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