The following data is part of a premarket notification filed by Jomed, Inc. with the FDA for Trak Back Ii.
| Device ID | K003938 |
| 510k Number | K003938 |
| Device Name: | TRAK BACK II |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | JOMED, INC. 1700 ROCKVILLE PIKE SUITE 400 Rockville, MD 20852 |
| Contact | Christina Kichula |
| Correspondent | Christina Kichula JOMED, INC. 1700 ROCKVILLE PIKE SUITE 400 Rockville, MD 20852 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-20 |
| Decision Date | 2001-01-18 |