The following data is part of a premarket notification filed by Ito Co., Ltd. with the FDA for Tm-300 Traction System.
| Device ID | K992545 |
| 510k Number | K992545 |
| Device Name: | TM-300 TRACTION SYSTEM |
| Classification | Equipment, Traction, Powered |
| Applicant | ITO CO., LTD. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey ITO CO., LTD. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-30 |
| Decision Date | 1999-09-01 |
| Summary: | summary |