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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-stammering
510(k) Number K962961
Device Name SUSTAINED PHONATION
Applicant
SURFACE MOUNT TECHNOLOGY, INC.
2181 PINNACLE PKWY.
TWINSBURG,  OH  44087
Applicant Contact ROGER ZIMMERMAN
Correspondent
SURFACE MOUNT TECHNOLOGY, INC.
2181 PINNACLE PKWY.
TWINSBURG,  OH  44087
Correspondent Contact ROGER ZIMMERMAN
Regulation Number874.5840
Classification Product Code
KTH  
Date Received07/30/1996
Decision Date 09/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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