| Device Classification Name |
General Purpose Reagent
|
| 510(k) Number |
K850845 |
| Device Name |
0.85% SALINE |
| Applicant |
| Micro Media Laboratories |
| 2775 Kurtz |
|
San Diego,
CA
92110
|
|
| Applicant Contact |
PETER G MARTIN |
| Correspondent |
| Micro Media Laboratories |
| 2775 Kurtz |
|
San Diego,
CA
92110
|
|
| Correspondent Contact |
PETER G MARTIN |
| Regulation Number | 864.4010 |
| Classification Product Code |
|
| Date Received | 03/01/1985 |
| Decision Date | 03/20/1985 |
| 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
|
|
|