Device Classification Name |
catheter, ventricular, general & plastic surgery
|
510(k) Number |
K881873 |
Device Name |
INTRODUCTION/DRAINAGE CATHETER & ACCESS |
Applicant |
SHERIDAN CATHETER CORP. |
ROUTE 40 |
ARGYLE,
NY
12809
|
|
Applicant Contact |
STEEN, PHD |
Correspondent |
SHERIDAN CATHETER CORP. |
ROUTE 40 |
ARGYLE,
NY
12809
|
|
Correspondent Contact |
STEEN, PHD |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 05/03/1988 |
Decision Date | 05/18/1988 |
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
|
|
|