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510(k) K923648

LECTRO-LARYNX by Bruce Medical Supply — Product Code ESE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1993
Date Received
July 21, 1992
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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