LEKSELL STEREOTACTIC SYSTEM
Holder, Head, Radiographic
DOWNS SURGICAL LTD.
The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Leksell Stereotactic System.
Pre-market Notification Details
| Device ID | K802140 |
| 510k Number | K802140 |
| Device Name: | LEKSELL STEREOTACTIC SYSTEM |
| Classification | Holder, Head, Radiographic |
| Applicant | DOWNS SURGICAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IWY |
| CFR Regulation Number | 892.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-04 |
| Decision Date | 1981-02-05 |
Trademark Results [LEKSELL STEREOTACTIC SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LEKSELL STEREOTACTIC SYSTEM 75257621 not registered Dead/Abandoned |
Elekta AB 1997-03-13 |
 LEKSELL STEREOTACTIC SYSTEM 73391725 not registered Dead/Abandoned |
AKTIEBOLAGET ELEKTA-INSTRUMENT 1982-09-29 |
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