LEKSELL STEREOTACTIC SYSTEM
Neurological Stereotaxic Instrument
ELEKTA INSTRUMENT AB
The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Stereotactic System.
Pre-market Notification Details
| Device ID | K972324 |
| 510k Number | K972324 |
| Device Name: | LEKSELL STEREOTACTIC SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ELEKTA INSTRUMENT AB 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson ELEKTA INSTRUMENT AB 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-23 |
| Decision Date | 1998-03-02 |
| Summary: | summary |
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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