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FDA 510(k) Application Details - K972106
Device Classification Name
Hearing Aid, Air Conduction
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510(K) Number
K972106
Device Name
Hearing Aid, Air Conduction
Applicant
PHONAK, INC.
850 E. DIEHL RD.
P.O. BOX 3017
NAPERVILLE, IL 60566 US
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Contact
LAURA M VOLL
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Regulation Number
874.3300
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Classification Product Code
ESD
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More FDA Info for this Product Code
Date Received
06/05/1997
Decision Date
08/15/1997
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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