Device Classification Name |
Catheter, Malecot
|
510(k) Number |
K954147 |
Device Name |
MANAN MALECOT BASKET DRAINAGE CATHETER |
Applicant |
MANAN MEDICAL PRODUCTS, INC. |
2200 CARLSON DR. |
NORTHBROOK,
IL
60062
|
|
Applicant Contact |
MICHAEL PLISHKA |
Correspondent |
MANAN MEDICAL PRODUCTS, INC. |
2200 CARLSON DR. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
MICHAEL PLISHKA |
Regulation Number | 876.5090
|
Classification Product Code |
|
Date Received | 09/05/1995 |
Decision Date | 03/26/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|