Device Classification Name |
Prosthesis, Nose, Internal
|
510(k) Number |
K880405 |
Device Name |
SILASTIC NASAL IMPLANT S-TYPE |
Applicant |
DOW CORNING WRIGHT |
P.O. BOX 100 |
ARLINGTON,
TN
38002
|
|
Applicant Contact |
LIPSCOMB, PHD |
Correspondent |
DOW CORNING WRIGHT |
P.O. BOX 100 |
ARLINGTON,
TN
38002
|
|
Correspondent Contact |
LIPSCOMB, PHD |
Regulation Number | 878.3680
|
Classification Product Code |
|
Date Received | 01/29/1988 |
Decision Date | 02/18/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|