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FDA 510(k) Application Details - K971080
Device Classification Name
Audiometer
More FDA Info for this Device
510(K) Number
K971080
Device Name
Audiometer
Applicant
BERNAFON-MAICO, INC.
9675 WEST 76TH ST.
EDEN PRAIRIE, MN 55344 US
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Contact
SCOTT SAVRE
Other 510(k) Applications for this Contact
Regulation Number
874.1050
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Classification Product Code
EWO
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More FDA Info for this Product Code
Date Received
03/25/1997
Decision Date
06/06/1997
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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