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FDA 510(k) Application Details - K955713
Device Classification Name
Hearing Aid, Bone Conduction
More FDA Info for this Device
510(K) Number
K955713
Device Name
Hearing Aid, Bone Conduction
Applicant
NOBELPHARMA USA, INC.
777 OAKMONT LN.
SUITE 100
WESTMONT, IL 60559 US
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Contact
MARY EDWARDS
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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
12/18/1995
Decision Date
08/09/1996
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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