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510(k) K960567

HF MEGA EAR by Maxi-Aids, Inc. — Product Code EPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1996
Date Received
February 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Group And Auditory Trainer
Device Class
Class II
Regulation Number
874.3320
Review Panel
EN
Submission Type

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