Device Classification Name |
tube, tympanostomy
|
510(k) Number |
K800727 |
Device Name |
GOODE T-TUBE, BIOLITE COATED SILICONE/TU |
Applicant |
XOMED, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
XOMED, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 04/01/1980 |
Decision Date | 04/16/1980 |
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
|
|
|