The following data is part of a premarket notification filed by Boyd Research, Inc. with the FDA for Clenchguard.
|Applicant||Boyd Research, Inc. 506 Pacific Ave Solana Beach, CA 92075|
Boyd Research, Inc. 5820 Bali Way S St. Pete Beach, FL 33706
|CFR Regulation Number||510(k) Premarket Notification [🔎]|
|Decision||Substantially Equivalent (SESE)|
|Regulation Medical Specialty||510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices|
|510k Review Panel||Dental|
|3rd Party Reviewed||No|