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510(k) K974132

VOICE MASTER PROSTHESIS by E. Benson Hood Lab, Inc. — Product Code EWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1998
Date Received
November 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Laryngeal (Taub)
Device Class
Class II
Regulation Number
874.3730
Review Panel
EN
Submission Type

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