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510(k) K901503

ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM by Stanton Magnetics, Inc. — Product Code ESE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1990
Date Received
March 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Larynx, Artificial (Battery-Powered)
Device Class
Class I
Regulation Number
874.3375
Review Panel
EN
Submission Type

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