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FDA 510(k) Application Details - K972552
Device Classification Name
Hearing Aid, Air Conduction
More FDA Info for this Device
510(K) Number
K972552
Device Name
Hearing Aid, Air Conduction
Applicant
TRUTONE
3113 SOUTH 115TH EAST AVE.
TULSA, OK 74146 US
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Contact
ZIAD SHWIYAT
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
06/30/1997
Decision Date
07/30/1997
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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