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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 K014079
Device Name DR. HAYS BITE GUARD
Applicant
INVENTIVE RESOURCES, INC.
200 GREGORY LN.
SUITE C-100
PLEASANT HILL,  CA  94523 -3389
Applicant Contact DAVID W SCHLERF
Correspondent
INVENTIVE RESOURCES, INC.
200 GREGORY LN.
SUITE C-100
PLEASANT HILL,  CA  94523 -3389
Correspondent Contact DAVID W SCHLERF
Classification Product Code
MQC  
Date Received12/11/2001
Decision Date 02/22/2002
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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