Device Classification Name |
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
|
510(k) Number |
K911324 |
Device Name |
IRRIGATION/ASPIRATION TUBING SET |
Applicant |
BIOMEDICAL DYNAMICS, INC. |
12250 NICOLLET AVE. |
BURNSVILLE,
MN
55337
|
|
Applicant Contact |
MATTHEW E BELLIN |
Correspondent |
BIOMEDICAL DYNAMICS, INC. |
12250 NICOLLET AVE. |
BURNSVILLE,
MN
55337
|
|
Correspondent Contact |
MATTHEW E BELLIN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 03/26/1991 |
Decision Date | 06/24/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|