The following data is part of a premarket notification filed by Segami Corporation with the FDA for Mirage Cedars Option.
Device ID | K070683 |
510k Number | K070683 |
Device Name: | MIRAGE CEDARS OPTION |
Classification | System, Image Processing, Radiological |
Applicant | SEGAMI CORPORATION 8325 GUILFORD RD., SUITE B Columbia, MD 21046 |
Contact | Philippe Briandet |
Correspondent | Philippe Briandet SEGAMI CORPORATION 8325 GUILFORD RD., SUITE B Columbia, MD 21046 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-12 |
Decision Date | 2007-04-12 |