| Device Classification Name |
Gauge, Depth
|
| 510(k) Number |
K864426 |
| Device Name |
RAYLOR(TM) DEPTH GAUGE |
| 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 |
| Regulation Number | 888.4300 |
| Classification Product Code |
|
| Date Received | 11/10/1986 |
| Decision Date | 11/26/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|