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FDA 510(k) Application Details - K152820
Device Classification Name
Hearing Aid, Bone Conduction, Implanted
More FDA Info for this Device
510(K) Number
K152820
Device Name
Hearing Aid, Bone Conduction, Implanted
Applicant
OTICON MEDICAL AB
DATAVAGEN 37B
ASKIM 436 32 SE
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Contact
CAROLINA ANKER WESSLING
Other 510(k) Applications for this Contact
Regulation Number
874.3300
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Classification Product Code
MAH
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More FDA Info for this Product Code
Date Received
09/28/2015
Decision Date
01/22/2016
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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