Device Classification Name |
collector, ostomy
|
510(k) Number |
K871738 |
Device Name |
OSTO-PURE |
Applicant |
CLEARCHEM CORP. |
2601 ADGATE RD. |
P.O. BOX 446 |
LIMA,
OH
45805
|
|
Applicant Contact |
ROBERT F HEIL |
Correspondent |
CLEARCHEM CORP. |
2601 ADGATE RD. |
P.O. BOX 446 |
LIMA,
OH
45805
|
|
Correspondent Contact |
ROBERT F HEIL |
Regulation Number | 876.5900
|
Classification Product Code |
|
Date Received | 05/05/1987 |
Decision Date | 08/12/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|