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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, anti-snoring
510(k) Number K973884
Device Name ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE
Applicant
FRANTZ DESIGN, INC.
400 MEDICAL CENTER, #209
WEBSTER,  TX  77598
Applicant Contact DONALD FRANTZ
Correspondent
FRANTZ DESIGN, INC.
400 MEDICAL CENTER, #209
WEBSTER,  TX  77598
Correspondent Contact DONALD FRANTZ
Regulation Number872.5570
Classification Product Code
LRK  
Date Received10/14/1997
Decision Date 01/09/1998
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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