The following data is part of a premarket notification filed by Ortho-graphics, Inc. with the FDA for Orthoplan.
| Device ID | K974406 |
| 510k Number | K974406 |
| Device Name: | ORTHOPLAN |
| Classification | Template |
| Applicant | ORTHO-GRAPHICS, INC. 100 NORTH MEDICAL DRIVE # 4550 Saltlake, UT 84113 |
| Contact | Peter M Stevens |
| Correspondent | Peter M Stevens ORTHO-GRAPHICS, INC. 100 NORTH MEDICAL DRIVE # 4550 Saltlake, UT 84113 |
| Product Code | HWT |
| CFR Regulation Number | 888.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-21 |
| Decision Date | 1998-02-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORTHOPLAN 85458799 4161304 Live/Registered |
SOUND TECHNOLOGIES, INC. 2011-10-28 |
![]() ORTHOPLAN 73662772 1502861 Dead/Cancelled |
ORTHO-GRAPHICS, INC. 1987-05-26 |
![]() ORTHOPLAN 72250622 0827849 Dead/Expired |
ERNST LEITZ, G.M.B.H. 1966-07-20 |