| Device Classification Name |
Container, Specimen, Sterile
|
| 510(k) Number |
K770387 |
| Device Name |
UNICATCH |
| Applicant |
| W.G. Whitney Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| W.G. Whitney Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 864.3250 |
| Classification Product Code |
|
| Date Received | 02/28/1977 |
| Decision Date | 04/05/1977 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Pathology
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|