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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intraoral, dental foam protector
510(k) Number K131396
Device Name WIRED MOUTH PROTECTOR (WMP)
Applicant
ELBA LABORATORIES, INC.
780 W. 8 MILE RD
FERNDALE,  MI  48220
Applicant Contact RICHARD A HAMER
Correspondent
ELBA LABORATORIES, INC.
780 W. 8 MILE RD
FERNDALE,  MI  48220
Correspondent Contact RICHARD A HAMER
Regulation Number872.6890
Classification Product Code
PFL  
Date Received05/15/2013
Decision Date 09/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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