| Device Classification Name |
Tape, Measuring, Rulers And Calipers
|
| 510(k) Number |
K862576 |
| Device Name |
PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) |
| Applicant |
| Professional Services For Surgeons, Ltd. |
| Official Correspondent |
| #1024 5220 Hedgewood Dr. |
|
Midland,
MI
48640
|
|
| Applicant Contact |
ARTHUR H RATHJEN |
| Correspondent |
| Professional Services For Surgeons, Ltd. |
| Official Correspondent |
| #1024 5220 Hedgewood Dr. |
|
Midland,
MI
48640
|
|
| Correspondent Contact |
ARTHUR H RATHJEN |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 07/07/1986 |
| Decision Date | 07/15/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|