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 |