The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Gammaplan.
Device ID | K090972 |
510k Number | K090972 |
Device Name: | LEKSELL GAMMAPLAN |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm, SE S-103 93 |
Contact | Anders Skoglund |
Correspondent | Anders Skoglund ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm, SE S-103 93 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-06 |
Decision Date | 2009-07-20 |
Summary: | summary |