The following data is part of a premarket notification filed by Nomos Corp. with the FDA for Nomosstat, Version 1.0.
Device ID | K060895 |
510k Number | K060895 |
Device Name: | NOMOSSTAT, VERSION 1.0 |
Classification | Accelerator, Linear, Medical |
Applicant | NOMOS CORP. 200 WEST KENSINGER DR. SUITE 100 Cranberry Township, PA 16066 |
Contact | Leigh Spotten |
Correspondent | Leigh Spotten NOMOS CORP. 200 WEST KENSINGER DR. SUITE 100 Cranberry Township, PA 16066 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-03 |
Decision Date | 2006-07-21 |