Device Classification Name |
Wound Dressing Kit
|
510(k) Number |
K912232 |
Device Name |
ULCERCARE |
Applicant |
JOBST INSTITUTE, INC. |
BOX 653 |
TOLEDO,
OH
43694
|
|
Applicant Contact |
ANGELO R PEREIRA |
Correspondent |
JOBST INSTITUTE, INC. |
BOX 653 |
TOLEDO,
OH
43694
|
|
Correspondent Contact |
ANGELO R PEREIRA |
Regulation Number | 880.5075
|
Classification Product Code |
|
Date Received | 05/20/1991 |
Decision Date | 08/14/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|