Device Classification Name |
collector, ostomy
|
510(k) Number |
K850751 |
Device Name |
DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY |
Applicant |
BIOLOG, INC. |
3447 INVESTMENT BLVD. STE 3 |
HAYWARD,
CA
94545
|
|
Applicant Contact |
DON BARNBY |
Correspondent |
BIOLOG, INC. |
3447 INVESTMENT BLVD. STE 3 |
HAYWARD,
CA
94545
|
|
Correspondent Contact |
DON BARNBY |
Regulation Number | 876.5900
|
Classification Product Code |
|
Date Received | 02/25/1985 |
Decision Date | 05/23/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|