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 |