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510(k) K854158

RESNICK EMITTER, ARTIFICIAL LARYNX by Dynamed Audio, Inc. — Product Code ESE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1985
Date Received
October 11, 1985
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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