| 510(k) Number |
K791348 |
| Device Name |
ROUND WASHBASIN & RECTANGLE WASHBASIN |
| Applicant |
| General Clinical Plastics Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| General Clinical Plastics Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Date Received | 07/12/1979 |
| Decision Date | 09/17/1979 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|