Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K801635 |
Device Name |
BIOBRANE BRAND TEMPORARY WOUND-DRESSING |
Applicant |
HALL-WOODROOF, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
HALL-WOODROOF, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Classification Product Code |
|
Date Received | 07/15/1980 |
Decision Date | 08/04/1980 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|