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510(k) K812864

SILASTIC VOICE PROSTHESIS by Dow Corning Corp. Healthcare Industries Materials — Product Code EWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1981
Date Received
October 13, 1981
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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  • K812053 — SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) (August 18, 1981)
  • K811679 — SILASTIC TENDON PASSER H.P. (July 10, 1981)
  • K801175 — SILASTIC II MAMMARY IMPLANT (December 18, 1980)

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