| Device Classification Name |
Clip, Scalp
|
| 510(k) Number |
K890443 |
| Device Name |
CASPAR SCALP CLIP, APPLIER |
| Applicant |
| Aesculap Instruments Corp. |
| 875 Stanton Rd. |
|
Burlingame,
CA
94010
|
|
| Applicant Contact |
ROBIN BUSH |
| Correspondent |
| Aesculap Instruments Corp. |
| 875 Stanton Rd. |
|
Burlingame,
CA
94010
|
|
| Correspondent Contact |
ROBIN BUSH |
| Regulation Number | 882.4150 |
| Classification Product Code |
|
| Date Received | 01/27/1989 |
| Decision Date | 06/15/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|