Device Classification Name |
Cannula, Sinus
|
510(k) Number |
K951803 |
Device Name |
ROSSITER SINUS STENT |
Applicant |
SMITH & NEPHEW RICHARDS, INC. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Applicant Contact |
RONALD K SMITH |
Correspondent |
SMITH & NEPHEW RICHARDS, INC. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Correspondent Contact |
RONALD K SMITH |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 04/19/1995 |
Decision Date | 05/11/1995 |
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
|
|
|