| 510(k) Number |
K851390 |
| Device Name |
STERILE GENERAL HOSPITAL SUPPLIES |
| Applicant |
| Biological & Environmental Control Laboratories |
| 615 Front St. |
|
Toledo,
OH
43605
|
|
| Applicant Contact |
NORMAN HUFF |
| Correspondent |
| Biological & Environmental Control Laboratories |
| 615 Front St. |
|
Toledo,
OH
43605
|
|
| Correspondent Contact |
NORMAN HUFF |
| Classification Product Code |
|
| Date Received | 04/09/1985 |
| Decision Date | 05/29/1985 |
| 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
|