The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Head Fiation Device (hfd 100).
| Device ID | K103493 |
| 510k Number | K103493 |
| Device Name: | HEAD FIATION DEVICE (HFD 100) |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | IMRIS, INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Contact | Thomas M Tskeris |
| Correspondent | Thomas M Tskeris IMRIS, INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-29 |
| Decision Date | 2011-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857534006394 | K103493 | 000 |
| 00857534006011 | K103493 | 000 |