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 |