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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 K193336
Device Name Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
Applicant
Synedgen, Inc.
1420 N. Claremont Blvd. Suite 105d
Claremont,  CA  91711
Applicant Contact Shenda Baker
Correspondent
Synedgen, Inc.
1420 N. Claremont Blvd. Suite 105d
Claremont,  CA  91711
Correspondent Contact Christopher Ryan
Classification Product Code
OLR  
Subsequent Product Code
MGQ  
Date Received12/02/2019
Decision Date 05/27/2020
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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