Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K851242 |
Device Name |
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO |
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 | 876.5010
|
Classification Product Code |
|
Date Received | 02/26/1985 |
Decision Date | 09/11/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|