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FDA 510(k) Application Details - K955692
Device Classification Name
Hearing Aid, Air Conduction
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510(K) Number
K955692
Device Name
Hearing Aid, Air Conduction
Applicant
FINETONE HEARING INSTRUMENTS
301 U.S. RT. 1
SCARBOROUGH, ME 04074 US
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Contact
JEFFREY A MCLAUGHLIN
Other 510(k) Applications for this Contact
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
12/14/1995
Decision Date
02/02/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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