| 510(k) Number |
K863964 |
| Device Name |
LIMB-GUARD |
| Applicant |
| Sparco, Inc. |
| P.O. Box 20369 |
|
Castro Valley,
CA
94546
|
|
| Applicant Contact |
BEVERLY J SPARKS |
| Correspondent |
| Sparco, Inc. |
| P.O. Box 20369 |
|
Castro Valley,
CA
94546
|
|
| Correspondent Contact |
BEVERLY J SPARKS |
| Date Received | 10/10/1986 |
| Decision Date | 10/24/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|