FDA 510(k) Application Details - K982396

Device Classification Name Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)

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510(K) Number K982396
Device Name Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
Applicant RSQ, LLC.
636 WELLESLEY DR.
CLAREMONT, CA 91711-3427 US
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Contact DORIS DRUCKER
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Regulation Number 000.0000

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Classification Product Code LEZ
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Date Received 07/09/1998
Decision Date 09/14/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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