The following data is part of a premarket notification filed by Hemedex Incorporated with the FDA for Hemedex Fixation Device.
| Device ID | K032127 |
| 510k Number | K032127 |
| Device Name: | HEMEDEX FIXATION DEVICE |
| Classification | Accessories, Catheter, G-u |
| Applicant | HEMEDEX INCORPORATED 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro HEMEDEX INCORPORATED 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Product Code | KNY |
| Subsequent Product Code | DPT |
| Subsequent Product Code | DPW |
| Subsequent Product Code | FGE |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-10 |
| Decision Date | 2003-12-30 |
| Summary: | summary |