Device Classification Name |
beads, hydrophilic, for wound exudate absorption
|
510(k) Number |
K896828 |
Device Name |
BIOCLUSIVE(R) ABSORBENT DRESSING |
Applicant |
JOHNSON & JOHNSON INTERNATIONAL |
410 GEORGE ST. |
NEW BRUNSWICK,
NJ
08901
|
|
Applicant Contact |
JAMES E MCCANN |
Correspondent |
JOHNSON & JOHNSON INTERNATIONAL |
410 GEORGE ST. |
NEW BRUNSWICK,
NJ
08901
|
|
Correspondent Contact |
JAMES E MCCANN |
Regulation Number | 878.4018
|
Classification Product Code |
|
Date Received | 12/04/1989 |
Decision Date | 11/21/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|