Device Classification Name |
system, peritoneal, automatic delivery
|
510(k) Number |
K901228 |
Device Name |
MULTI-STRIP |
Applicant |
BELLHOUSE MEDICAL, INC. |
2933 MANNING AVENUE NORTH |
LAKE ELMO,
MN
55042
|
|
Applicant Contact |
JULIA JACKSON |
Correspondent |
BELLHOUSE MEDICAL, INC. |
2933 MANNING AVENUE NORTH |
LAKE ELMO,
MN
55042
|
|
Correspondent Contact |
JULIA JACKSON |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 03/14/1990 |
Decision Date | 05/07/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|