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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, vocal cord medialization
510(k) Number K000533
Device Name VOCOM IMPLANT- 8MM
Applicant
SMITH & NEPHEW, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Applicant Contact ALICIA FARAGE
Correspondent
SMITH & NEPHEW, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Correspondent Contact ALICIA FARAGE
Regulation Number874.3620
Classification Product Code
MIX  
Date Received02/17/2000
Decision Date 03/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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