The following data is part of a premarket notification filed by Hemedex Incorporated with the FDA for Hemedex Cranial Bolt Models, 3601, 3602.
| Device ID | K032337 |
| 510k Number | K032337 |
| Device Name: | HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 |
| Classification | Device, Monitoring, Intracranial Pressure |
| 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 | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-29 |
| Decision Date | 2003-10-21 |
| Summary: | summary |