Device Classification Name |
tube, tympanostomy
|
510(k) Number |
K062385 |
FOIA Releasable 510(k) |
K062385
|
Device Name |
BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES |
Applicant |
Grace Medical, Inc. |
8500 WOLF LAKE DR., STE. 110 |
MEMPHIS,
TN
38133
|
|
Applicant Contact |
JEFF COBB |
Correspondent |
Grace Medical, Inc. |
8500 WOLF LAKE DR., STE. 110 |
MEMPHIS,
TN
38133
|
|
Correspondent Contact |
JEFF COBB |
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 08/15/2006 |
Decision Date | 09/27/2006 |
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
|
|
|