| 510(k) Number |
K822484 |
| Device Name |
INFECTION CONTROL TOWEL |
| Applicant |
| American Threshold Industries, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| American Threshold Industries, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Classification Product Code |
|
| Date Received | 08/17/1982 |
| Decision Date | 09/30/1982 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|