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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name polymer, ent synthetic-polyamide (mesh or foil material)
510(k) Number K974311
Device Name VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT
Applicant
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT,  TN  38133
Applicant Contact ALICIA FARAGE
Correspondent
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT,  TN  38133
Correspondent Contact ALICIA FARAGE
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received11/17/1997
Decision Date 03/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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