FDA 510(k) Application Details - K962961

Device Classification Name Device, Anti-Stammering

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510(K) Number K962961
Device Name Device, Anti-Stammering
Applicant SURFACE MOUNT TECHNOLOGY, INC.
2181 PINNACLE PKWY.
TWINSBURG, OH 44087 US
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Contact ROGER ZIMMERMAN
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Regulation Number 874.5840

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Classification Product Code KTH
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Date Received 07/30/1996
Decision Date 09/09/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K962961


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