| Device Classification Name |
Retractor, Self-Retaining, For Neurosurgery
|
| 510(k) Number |
K905445 |
| Device Name |
ADSON-BECKMAN RETRACTOR, SPINAL |
| Applicant |
| A. Henniss |
| 18321 Ventura Blvd., |
| Suite 1010 |
|
Tarzana,
CA
91356
|
|
| Applicant Contact |
GEORGE O SHECTER |
| Correspondent |
| A. Henniss |
| 18321 Ventura Blvd., |
| Suite 1010 |
|
Tarzana,
CA
91356
|
|
| Correspondent Contact |
GEORGE O SHECTER |
| Regulation Number | 882.4800 |
| Classification Product Code |
|
| Date Received | 12/04/1990 |
| Decision Date | 01/25/1991 |
| 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
|
|
|