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FDA 510(k) Application Details - K954922
Device Classification Name
Hearing Aid, Air Conduction
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510(K) Number
K954922
Device Name
Hearing Aid, Air Conduction
Applicant
REXTON, INC.
2415 XENIUM LN.
PLYMOUTH, MN 55441 US
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Contact
DAN ANDERSON
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Regulation Number
874.3300
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Classification Product Code
ESD
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Date Received
10/26/1995
Decision Date
01/17/1996
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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