Device Classification Name |
garment, protective, for incontinence
|
510(k) Number |
K840679 |
Device Name |
SERENITY CONTOURED ABSORBENT SHIELDS |
Applicant |
JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. |
GRANDVIEW RD. |
SKILLMAN,
NJ
08558
|
|
Correspondent |
JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. |
GRANDVIEW RD. |
SKILLMAN,
NJ
08558
|
|
Regulation Number | 876.5920
|
Classification Product Code |
|
Date Received | 02/15/1984 |
Decision Date | 03/22/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|