| Device Classification Name |
Device, General Purpose, Microbiology, Diagnostic
|
| 510(k) Number |
K871559 |
| Device Name |
CELL LIFTER |
| Applicant |
| Corning Costar Corp. |
| Alewive Rd. |
|
Kennebunk,
ME
04043
|
|
| Applicant Contact |
PETER C SUTCLIFFE |
| Correspondent |
| Corning Costar Corp. |
| Alewive Rd. |
|
Kennebunk,
ME
04043
|
|
| Correspondent Contact |
PETER C SUTCLIFFE |
| Regulation Number | 866.2660 |
| Classification Product Code |
|
| Date Received | 04/22/1987 |
| Decision Date | 05/15/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Microbiology
|
| 510k Review Panel |
Microbiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|