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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 K181005
Device Name ClenchGuard
Applicant
Boyd Research, Inc.
506 Pacific Ave
Solana Beach,  CA  92075
Applicant Contact James Boyd
Correspondent
Boyd Research, Inc.
5820 Bali Way S
St. Pete Beach,  FL  33706
Correspondent Contact James Boyd
Classification Product Code
OBR  
Date Received04/16/2018
Decision Date 01/15/2020
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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