The following data is part of a premarket notification filed by Daejin Tech Medical Manufacturing Co., Ltd. with the FDA for Top Fine.
| Device ID | K063466 |
| 510k Number | K063466 |
| Device Name: | TOP FINE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | DAEJIN TECH MEDICAL MANUFACTURING CO., LTD. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm DAEJIN TECH MEDICAL MANUFACTURING CO., LTD. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-16 |
| Decision Date | 2007-03-02 |
| Summary: | summary |