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FDA 510(k) Application Details - K960680
Device Classification Name
Hearing Aid, Air Conduction
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510(K) Number
K960680
Device Name
Hearing Aid, Air Conduction
Applicant
RESOUND CORP.
220 SAGINAW DRIVE,
SEAPORT CENTRE
REDWOOD CITY, CA 94063 US
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Contact
KRISTA M BUCKLES
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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
02/20/1996
Decision Date
04/10/1996
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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