The following data is part of a premarket notification filed by Therapeutic Clinical Technologies, Inc. with the FDA for Gravilax Traction System.
| Device ID | K072064 |
| 510k Number | K072064 |
| Device Name: | GRAVILAX TRACTION SYSTEM |
| Classification | Equipment, Traction, Powered |
| Applicant | THERAPEUTIC CLINICAL TECHNOLOGIES, INC. 5335 WISCONSIN AVE., SUITE 440 Washington, DC 20016 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli THERAPEUTIC CLINICAL TECHNOLOGIES, INC. 5335 WISCONSIN AVE., SUITE 440 Washington, DC 20016 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-27 |
| Decision Date | 2008-04-21 |
| Summary: | summary |