Device Classification Name |
Catheter, Irrigation
|
510(k) Number |
K843617 |
Device Name |
SDC SILICONE SUMP DRAIN |
Applicant |
SCIENCE DEVELOPMENT CORP. |
6 PEARL COURT |
ALLENDALE ,
NJ
07401 -
|
|
Applicant Contact |
GEORGE E KING |
Correspondent |
SCIENCE DEVELOPMENT CORP. |
6 PEARL COURT |
ALLENDALE ,
NJ
07401 -
|
|
Correspondent Contact |
GEORGE E KING |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 09/14/1984 |
Decision Date | 10/24/1984 |
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
|
|
|