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510(k) K912486

SINGH SPEECH SYSTEM (SERIES 'SSS') by Exmoor Plastics , Ltd. — Product Code EWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1992
Date Received
June 4, 1991
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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  • K973587 — EXMOOR TYMPANOCENTESIS KIT (TK/1) (January 23, 1998)

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