The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Hfd100 Rocker Arm Accessory.
| Device ID | K141950 |
| 510k Number | K141950 |
| Device Name: | HFD100 ROCKER ARM ACCESSORY |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | IMRIS, INC. 5101 Shady Oak Rd Minnetonka, MN 55343 |
| Contact | Karissa Holcomb |
| Correspondent | Karissa Holcomb IMRIS, INC. 5101 Shady Oak Rd Minnetonka, MN 55343 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-18 |
| Decision Date | 2014-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857534006264 | K141950 | 000 |