Device Classification Name |
Indicator, Physical/Chemical Sterilization Process
|
510(k) Number |
K811936 |
Device Name |
CHEMICAL AUTOCLAVE INDICATOR TAPE |
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 | 880.2800 |
Classification Product Code |
|
Date Received | 07/06/1981 |
Decision Date | 07/28/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|