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FDA 510(k) Application Details - K100193
Device Classification Name
Hearing Aid, Bone Conduction
More FDA Info for this Device
510(K) Number
K100193
Device Name
Hearing Aid, Bone Conduction
Applicant
SOPHONO, INC
555 ZANG STREET
SUITE 100
LAKEWOOD, CO 80228 US
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Contact
Mary Armstrong
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Regulation Number
874.3300
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Classification Product Code
LXB
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More FDA Info for this Product Code
Date Received
01/22/2010
Decision Date
05/18/2010
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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