Device Classification Name |
gown, isolation, surgical
|
510(k) Number |
K760904 |
Device Name |
CLEANING AND ISOLATION ROOM KIT |
Applicant |
AMERICAN HOSPITAL SUPPLY CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AMERICAN HOSPITAL SUPPLY CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 10/26/1976 |
Decision Date | 12/30/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|