| 510(k) Number |
K864423 |
| Device Name |
RAYLOR(TM) OSTEOTOMES |
| Applicant |
| Cedar Surgical, Inc. |
| 15265 Minnetonka Blvd. |
|
Minnetonka,
MN
55345
|
|
| Applicant Contact |
TERRY P CORBIN |
| Correspondent |
| Cedar Surgical, Inc. |
| 15265 Minnetonka Blvd. |
|
Minnetonka,
MN
55345
|
|
| Correspondent Contact |
TERRY P CORBIN |
| Date Received | 11/10/1986 |
| Decision Date | 11/24/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|