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510(k) K934483

NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX by Mountain Precision Mfg. Ltd. Co. — Product Code ESE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1994
Date Received
September 14, 1993
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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