FDA 510(k) Application Details - K150065

Device Classification Name Masker, Tinnitus

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510(K) Number K150065
Device Name Masker, Tinnitus
Applicant SoundCure, Inc.
560 S Winchester Blvd STE 500
San Jose, CA 95128 US
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Contact William Perry
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Regulation Number 874.3400

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Classification Product Code KLW
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Date Received 01/13/2015
Decision Date 04/13/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
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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