Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K833731 |
Device Name |
BREATHABLE OVERWRAY BANDAGE NON-ELAS |
Applicant |
AMERICAN MEDICAL DISPOSABLE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AMERICAN MEDICAL DISPOSABLE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 10/25/1983 |
Decision Date | 01/27/1984 |
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
|
|
|