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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mouthguard, over-the-counter
510(k) Number K231865
Device Name Mouth Guard (ATG0603R)
Applicant
Reazeal Corp
1226 North King St. #485
Wilmington,  DE  19801
Applicant Contact Liu Fuhua
Correspondent
Shanghai Sungo Management Consulting Company Limited
14th Floor, 1500# Central Avenue
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Classification Product Code
OBR  
Date Received06/26/2023
Decision Date 11/06/2023
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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