The following data is part of a premarket notification filed by Professional Services For Surgeons, Ltd. with the FDA for Ps2 Brand Facial Symmetry Guide (lee Design).
| Device ID | K862576 |
| 510k Number | K862576 |
| Device Name: | PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) |
| Classification | Tape, Measuring, Rulers And Calipers |
| Applicant | PROFESSIONAL SERVICES FOR SURGEONS, LTD. OFFICIAL CORRESPONDENT #1024 5220 HEDGEWOOD DRIVE Midland, MI 48640 |
| Contact | Arthur H Rathjen |
| Correspondent | Arthur H Rathjen PROFESSIONAL SERVICES FOR SURGEONS, LTD. OFFICIAL CORRESPONDENT #1024 5220 HEDGEWOOD DRIVE Midland, MI 48640 |
| Product Code | FTY |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-07 |
| Decision Date | 1986-07-15 |