Device Classification Name |
bandage, liquid
|
510(k) Number |
K781406 |
Device Name |
HYDRON BURN BANDAGE MANUAL APPLICATION |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 08/14/1978 |
Decision Date | 09/07/1978 |
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
|
|
|