Device Classification Name |
Collector, Ostomy
|
510(k) Number |
K810812 |
Device Name |
DRAINING-WOUND MGMT. SYSTEM |
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 | 03/24/1981 |
Decision Date | 04/17/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|