Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K903347 |
Device Name |
SODIUM CHLORIDE SOLUTION |
Applicant |
SUPERIOR HEALTHCARE GROUP, INC. |
CUMBERLAND INDUSTRIAL PARK |
CUMBERLAND,
RI
02864
|
|
Applicant Contact |
MAUREEN G MCCABE |
Correspondent |
SUPERIOR HEALTHCARE GROUP, INC. |
CUMBERLAND INDUSTRIAL PARK |
CUMBERLAND,
RI
02864
|
|
Correspondent Contact |
MAUREEN G MCCABE |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 07/25/1990 |
Decision Date | 12/13/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|