Device Classification Name |
Tube, Tympanostomy
|
510(k) Number |
K974008 |
Device Name |
PFLEIDERER'S INTRATYMPANIC CATHETER |
Applicant |
EXMOOR PLASTICS LTD. |
LISIEUX WAY |
TAUNTON, SOMERSET,
GB
TA1 2LB
|
|
Applicant Contact |
MARGARET BLACKMORE |
Correspondent |
EXMOOR PLASTICS LTD. |
LISIEUX WAY |
TAUNTON, SOMERSET,
GB
TA1 2LB
|
|
Correspondent Contact |
MARGARET BLACKMORE |
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 10/17/1997 |
Decision Date | 05/13/1998 |
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
|
|
|