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FDA 510(k) Application Details - K100649
Device Classification Name
Hearing Aid, Bone Conduction
More FDA Info for this Device
510(K) Number
K100649
Device Name
Hearing Aid, Bone Conduction
Applicant
SONITUS MEDICAL INC
25 HARTFORD AVE
SAN CARLOS, CA 94070 US
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Contact
ROBERT J CHIN
Other 510(k) Applications for this Contact
Regulation Number
874.3300
More FDA Info for this Regulation Number
Classification Product Code
LXB
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More FDA Info for this Product Code
Date Received
03/08/2010
Decision Date
01/14/2011
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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