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FDA 510(k) Application Details - K960229
Device Classification Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
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510(K) Number
K960229
Device Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
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
874.3310
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Classification Product Code
ETW
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More FDA Info for this Product Code
Date Received
01/17/1996
Decision Date
03/07/1996
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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