Device Classification Name |
Replacement, Ossicular Prosthesis, Total
|
510(k) Number |
K001902 |
Device Name |
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD |
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 Number | 874.3495
|
Classification Product Code |
|
Date Received | 06/22/2000 |
Decision Date | 07/10/2000 |
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
|
|
|