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510(k) K970340

AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER by Bellab — Product Code LZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1997
Date Received
January 29, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Assistive Listening
Device Class
Class II
Regulation Number
874.3320
Review Panel
EN
Submission Type

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