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FDA 510(k) Application Details - K974751
Device Classification Name
Hearing Aid, Air Conduction
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510(K) Number
K974751
Device Name
Hearing Aid, Air Conduction
Applicant
GENERAL HEARING INSTRUMENTS, INC.
175 BROOKHOLLOW ESPL.
HARAHAN, LA 70123 US
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Contact
ROGER P JUNEAU
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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
12/19/1997
Decision Date
03/06/1998
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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