The following data is part of a premarket notification filed by Therasys, Inc. with the FDA for Ctd Mark I Traction Device.
| Device ID | K991931 |
| 510k Number | K991931 |
| Device Name: | CTD MARK I TRACTION DEVICE |
| Classification | Equipment, Traction, Powered |
| Applicant | THERASYS, INC. 2295 NORTH MORAINE DR. Moraine, OH 45439 |
| Contact | Earnie S Philpot |
| Correspondent | Earnie S Philpot THERASYS, INC. 2295 NORTH MORAINE DR. Moraine, OH 45439 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-08 |
| Decision Date | 1999-08-12 |