Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K953019 |
Device Name |
HYDROPHILIC FOAM DRESSING |
Applicant |
BUSSE HOSPITAL DISPOSABLES, INC. |
P.O. BOX 11067 |
HAUPPAUGE,
NY
11788
|
|
Applicant Contact |
EILEEN RAMA |
Correspondent |
BUSSE HOSPITAL DISPOSABLES, INC. |
P.O. BOX 11067 |
HAUPPAUGE,
NY
11788
|
|
Correspondent Contact |
EILEEN RAMA |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 06/29/1995 |
Decision Date | 09/15/1995 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|