Device Classification Name |
catheter, intravascular, therapeutic, long-term greater than 30 days
|
510(k) Number |
K851243 |
Device Name |
GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION |
Applicant |
COOK, INC. |
UNIV. OF MEDICINE & DENTISTRY |
OF NJ RUTGERS MEDICAL SCHOOL |
NEW BRUNSWICK,
NJ
08903
|
|
Correspondent |
COOK, INC. |
UNIV. OF MEDICINE & DENTISTRY |
OF NJ RUTGERS MEDICAL SCHOOL |
NEW BRUNSWICK,
NJ
08903
|
|
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 02/26/1985 |
Decision Date | 03/14/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|