The following data is part of a premarket notification filed by Circular Traction Supply, Inc. with the FDA for Ctbox Cervical/lumbar Traction.
| Device ID | K063353 |
| 510k Number | K063353 |
| Device Name: | CTBOX CERVICAL/LUMBAR TRACTION |
| Classification | Equipment, Traction, Powered |
| Applicant | CIRCULAR TRACTION SUPPLY, INC. 7602 TALBERT AVENUE, UNIT #9 Huntington Beach, CA 92648 |
| Contact | Donald W Meyer |
| Correspondent | Donald W Meyer CIRCULAR TRACTION SUPPLY, INC. 7602 TALBERT AVENUE, UNIT #9 Huntington Beach, CA 92648 |
| Product Code | ITH |
| Subsequent Product Code | ILZ |
| Subsequent Product Code | IRS |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-06 |
| Decision Date | 2007-03-14 |
| Summary: | summary |