The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Elekta Stereotactic Guide.
Device ID | K991636 |
510k Number | K991636 |
Device Name: | ELEKTA STEREOTACTIC GUIDE |
Classification | Neurological Stereotaxic Instrument |
Applicant | ELEKTA INSTRUMENT AB 21911 ERIE LN. Lake Forest, CA 92630 |
Contact | Carol Patterson |
Correspondent | Carol Patterson ELEKTA INSTRUMENT AB 21911 ERIE LN. Lake Forest, CA 92630 |
Product Code | HAW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-05-12 |
Decision Date | 1999-07-20 |
Summary: | summary |