The following data is part of a premarket notification filed by Mclaren Health Care Corporation with the FDA for Mclaren Proton Therapy System.
Device ID | K160063 |
510k Number | K160063 |
Device Name: | McLaren Proton Therapy System |
Classification | System, Radiation Therapy, Charged-particle, Medical |
Applicant | McLaren Health Care Corporation G-3235 Beecher Rd., Suite B Flint, MI 48532 |
Contact | Ryan Vlcko |
Correspondent | Daniel Gottlieb Epstein Becker & Green, P.C. 1227 25th St. NW Ste. 700 Washington, DC 20037 |
Product Code | LHN |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-01-13 |
Decision Date | 2016-02-25 |
Summary: | summary |