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FDA 510(k) Application Details - K211008
Device Classification Name
More FDA Info for this Device
510(K) Number
K211008
Device Name
Bose SoundControl Hearing Aids
Applicant
Bose Corporation
The Mountain
Framingham, MA 01701 US
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Contact
Bryn Kieras
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QDD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/05/2021
Decision Date
05/05/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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