The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Stereotactic System With Reusable Fixation Screws.
Device ID | K080355 |
510k Number | K080355 |
Device Name: | LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS |
Classification | Neurological Stereotaxic Instrument |
Applicant | ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm, SE S-103 93 |
Contact | Peter Lowendahl |
Correspondent | Peter Lowendahl ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm, SE S-103 93 |
Product Code | HAW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-02-11 |
Decision Date | 2009-05-01 |
Summary: | summary |