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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K240463
Device Name Slow Wave DS8 (SWDS802)
Applicant
Slow Wave Inc.
26100 Countryside Dr.
Spicewood,  TX  78669
Applicant Contact Sam Murray
Correspondent
Slow Wave Inc.
26100 Countryside Dr.
Spicewood,  TX  78669
Correspondent Contact Sam Murray
Classification Product Code
MQC  
Subsequent Product Code
OCO  
Date Received02/16/2024
Decision Date 06/04/2024
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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