Device Classification Name |
collector, ostomy
|
510(k) Number |
K802677 |
Device Name |
CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON |
Applicant |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Correspondent |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Regulation Number | 876.5900
|
Classification Product Code |
|
Date Received | 10/29/1980 |
Decision Date | 11/12/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|