MODULAR PORP AND TORP MODEL TBD


information about

Device Classification Name

replacement, ossicular prosthesis, total

510(k) Number K002378
Device Name MODULAR PORP AND TORP MODEL TBD
Original Applicant
GYRUS ENT L.L.C.
2925 appling rd.
bartlett, 
TN 
38133

Original Contact alicia farage
Regulation Number 874.3495
Classification Product Code
ETA  
Subsequent Product Code
ETB  
Date Received 08/04/2000
Decision Date 08/29/2000
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