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 |