Device Classification Name |
polymer, ent synthetic-polyamide (mesh or foil material)
|
510(k) Number |
K972700 |
Device Name |
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) |
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 | 874.3620
|
Classification Product Code |
|
Date Received | 06/18/1997 |
Decision Date | 07/16/1998 |
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
|
|
|