| Device Classification Name |
Slide Stainer, Automated
|
| 510(k) Number |
K881592 |
| Device Name |
WESCOR MODEL 7300 AEROSPRAY GRAM STAINER |
| Applicant |
| Wescor, Inc. |
| 459 S. Main |
|
Logan,
UT
84321
|
|
| Applicant Contact |
WAYNE K BARLOW |
| Correspondent |
| Wescor, Inc. |
| 459 S. Main |
|
Logan,
UT
84321
|
|
| Correspondent Contact |
WAYNE K BARLOW |
| Regulation Number | 864.3800 |
| Classification Product Code |
|
| Date Received | 04/12/1988 |
| Decision Date | 05/13/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Pathology
|
| 510k Review Panel |
Pathology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|