WEHRS INCUS-STAPES

Prosthesis, Partial Ossicular Replacement

GYRUS ENT L.L.C.

The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Wehrs Incus-stapes.

Pre-market Notification Details

Device IDK000858
510k NumberK000858
Device Name:WEHRS INCUS-STAPES
ClassificationProsthesis, Partial Ossicular Replacement
Applicant GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett,  TN  38133
ContactAlicia Farage
CorrespondentAlicia Farage
GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett,  TN  38133
Product CodeETB  
CFR Regulation Number874.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-16
Decision Date2000-04-03

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